Search

Introduction: The concept of failure in breast reconstruction can occur when negative outcomes dominate the patient experience. The primary objective of this review was to identify experiences of failure in breast reconstruction from the patient's perspective in the qualitative literature. Methods: MEDLINE, Embase, Psychinfo, Emcare, and CINAHL were searched on July 31, 2023 using terms related to breast reconstruction and qualitative research. Thematic analysis was performed on direct quotations from included studies. Confidence in the Evidence from Reviews of Qualitative (CERQual) Research was used to assess confidence of the final findings. Results: Forty-two studies were identified. The following themes were identified in breast reconstruction failure : (1) failure occurs when expectations of restoring the original breast are not met with reconstruction, (2) failure occurs when unexpected outcomes were associated with the reconstruction, and (3) healthcare providers negatively impact the experience of breast reconstruction failure through lack of transparency when educating patients on expected results and poor relational support in the post-operative period. The evidence supporting themes 1-3 scored high confidence with CERQual. Conclusion: Breast reconstruction failure from the patient perspective arises from the limitations and adverse outcomes of the surgery. They may also arise even when the procedure was deemed "successful" from the surgeon's perspective. Dissatisfaction with result is increased by procedural complications. Healthcare providers can aggravate the perception of failure through inadequate patient education. Incorporating these perceptions of failure into discussions with patients can aid in their decision making., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Thoma is an editor of the book Evidence-Based Surgery: A Guide for Understanding and Interpreting the Surgical Literature and receives royalties from SPRINGER. The other authors have no conflict of interest to report., (© 2025 The Author(s).)

Purpose: Well-designed pilot trials are essential in determining feasibility prior to initiating definitive randomized controlled trials (RCTs) and their implementation into clinical practice. The primary outcome of this study was to identify the number of pilot or feasibility studies in Plastic Surgery that progressed to a definitive RCT. Secondary outcomes included a) number of pilot studies expressing feasibility statements and outcomes and b) reporting quality., Methods: MEDLINE, Embase, Web of Science, and clinicaltrials.gov were searched for all pilot RCTs and definitive RCTs in plastic surgery between 2012-2023. Pilot trials were matched to definitive RCTs by keyword, author, and citation report. Feasibility outcomes were presented using descriptive statistics. Reporting quality was evaluated using the Consolidated Standards of Reporting Trials 2010 randomized pilot and feasibility trials extension., Results: Among 11,540 and 6035 citations screened in 2 separate literature searches, 171 pilot studies and 779 definitive RCTS were included, respectively. Ten (5.8%) pilot studies were associated with a completed RCT, 4 (2.3%) were in progress, and 2 (1.2%) were stopped. For studies that did not progress to a definitive RCT, "inadequate funding" (n = 11, 41.4%) was the most cited reason followed by "insufficient efficacy to justify study progression" (n = 5, 17.3%). The average reporting adherence to the Consolidated Standards of Reporting Trials items was 65.6% (SD 16). Fifty (29.2%) pilot RCTs reported a feasibility statement and 30 (17.5%) reported feasibility outcomes., Conclusions: Few pilot trials in plastic surgery progressed to a definitive RCT, and most did not present feasibility statements or outcomes. Pilot studies should precede RCTs and include clear feasibility statements and outcomes., Competing Interests: Conflicts of interest and source of funding: Dr. Thoma is an editor of the book Evidence-Based Surgery: A Guide for Understanding and Interpreting the Surgical Literature and receives royalties from SPRINGER. All of the remaining authors have no conflicts of interest to declare. No funding was received for this work., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: In effort to improve post-operative outcomes, enhanced recovery after surgery (ERAS) protocols have gained popularity. The objective of this systematic review was to assess the reporting and methodological quality of plastic surgery ERAS studies., Methods: All plastic surgery ERAS implementation studies, published between January 1, 2020, to November 20, 2023, were included. The primary outcome was reporting quality based on "The Reporting on ERAS Compliance, Outcomes, and Elements Research (RECOvER) checklist" (40 points). Secondary outcomes included methodology quality as per ERAS® Society endorsed guidelines (Breast 18 points; Head and Neck (H&N) 24 points)., Results: Fifty ERAS studies were included (breast reconstruction: 29, 58%; head and neck: 7, 14%; craniofacial: 6, 12%; aesthetic: 5, 10%; other: 3, 6%). Average reporting quality was 22.6/40 (56.7%). ERAS protocol elements least adhered to included: patient warming strategy (8/50, 16%), management of post-operative fluids (14/50, 28%), and post-discharge outcome tracking (14/50, 28%). Evaluation of breast methodological quality revealed average compliance of 9.2/18 (51.3%). The least complied with elements included preoperative computed tomography angiography (4/23, 17.4%), intraoperative warming (6/23, 26.1%), and post-operative wound management (2/23, 8.7%). For head and neck studies, average compliance was 9.1/23 (39.6%). The least complied with elements included pre-anesthesia pain medications (1/7, 14.3%), post-operative wound care (0/7, 0%), and urinary catheterization removal (1/7, 14.3%)., Conclusions: ERAS implementation studies in plastic surgery are highly variable, with overall low reporting and methodology quality. Plastic surgeons should be cautious when adopting published ERAS protocols that do not adhere to the recommended and official ERAS® Society guidelines., Competing Interests: Conflict of interest statement The authors declare that there are no relevant conflicts of interest. Dr. Thoma is an Editor of the book Evidence-Based Surgery: A Guide for Understanding and Interpreting the Surgical Literature and receives royalties from SPRINGER., (Copyright © 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background and Purpose: Clinicians use the CTCAE scale to grade radiation dermatitis (RD) based on edema, erythema, and desquamation. The purpose of this study was to correlate the CTCAE scores with the severity of patient-reported symptoms using a skin symptom assessment (SSA) and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS)., Materials and Methods: This is a secondary analysis of a randomized controlled trial involving 376 patients receiving Mepitel Film or standard-of-care for RD prophylaxis. The highest symptom categories for SSA and patient-component RISRAS assessments were selected from all time points, and a summary analysis and Spearman correlation coefficient was calculated for patients with CTCAE Grades 0, 1, 2, 3, and Grade 2/3, respectively. Analyses were conducted across all patients, within each treatment arm, and between arms in patients with only Grade 2 or 3 toxicity., Results: Weak correlations between CTCAE scores and all patient-reported skin symptoms were found across the entire cohort and each treatment arm (p < 0.05). Patients with Grade 2 (n = 72) and Grade 3 RD (n = 24) reported similar rates of patient-reported moderate-to-severe skin symptoms (11-72% vs 14-79%), with no significant difference in rates of individual moderate-to-severe symptom between these cohorts (p > 0.05). Between treatment arms, rates of patient-reported moderate-to-severe scores were similar for most symptoms., Conclusion: CTCAE RD scores are weakly correlated with patient-reported skin symptoms and cannot distinguish between patients with severe patient-reported outcomes. Clinicians should consider the limitations of CTCAE grading and incorporate patient-reported outcomes within clinical practice., Competing Interests: Declarations Ethics approval This research was conducted in accordance with the Declaration of Helsinki. Human ethics and consent to participate declarations were not applicable. Competing Interests The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background and Purpose: The study evaluated the concordance between patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) of acute radiation dermatitis (RD) symptoms following adjuvant radiotherapy for early-stage and locally advanced breast cancer., Material and Methods: This is a secondary analysis of a multi-center randomized phase 3 trial (376 patients). Ordinal logistic regression analysis was used to compare the Skin Symptom Assessment (SSA) independently reported by both patients and clinicians. Concordance between patient- and clinician-reported SSAs for RD symptoms was measured by percent concordance, concordance index (C-statistic), and Cohen's Kappa. Analyses were performed across all patients in the original modified intention-to-treat analysis and those with only grade 2-3 (CTCAE) RD., Results: PROs were significantly more severe than CROs across all RD symptoms (Odds Ratio [OR] > 1; p < 0.0001). Pigmentation (OR 5.4), blistering/peeling (OR 4.0), and pain/soreness (OR 3.9) were the most differentially reported symptoms. Poor-to-low concordance was noted between patient- and clinician-reported SSAs for all RD symptoms for the entire cohort (percent concordance < 50%, C-statistic 0.52-0.63, Cohen's Kappa 13.9-23.4%) and those with grade 2-3 RD (percent concordance < 50%, C-statistic 0.56-0.66, Cohen's Kappa 2.0-24.5%). Similarly, poor-to-low concordance was noted in both Mepitel film and standard-of-care arms., Conclusion: PROs and CROs have poor concordance in breast RD, and patients report worse outcomes than clinicians, regardless of RD severity or prophylaxis. PROs must be further integrated into routine clinical practice and clinical trial design to reduce the risk of underreporting symptoms., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

A clinical practice guideline (CPG) from the American Society of Plastic Surgeons recommended not to use drains in breast reduction. This CPG was based on 3 randomized controlled trials (RCTs). The objective of this review was to double-check the methodological quality of the 3 RCTs. These RCTs were critically appraised using: (1) the "User's Guide to the Surgical Literature" checklist to critically appraise the methodological quality, (2) the CONSORT guidelines for reporting quality, and (3) the Cochrane risk-of-bias tool 2 (RoB 2) for risk of bias. Weaknesses were identified in all assessments for the 3 RCTs. Items with the poorest adherence in the "User's Guide" included: "Were patients stratified?," "Was follow-up complete?," and "Were all clinically important outcomes considered?" The overall adherence to the CONSORT reporting checklist across all 3 studies was moderate with 40.0%, 62.1%, and 48.3% adherence. All 3 RCTs had a similar low to moderate risk of bias, with no areas with a high risk of bias. None of the studies took into consideration a single critical outcome (such as major hematoma) and the outcome's minimally important difference as the basis for the sample size and power calculation of the study. All 3 RCTs additionally lacked clear reporting of treatment effect sizes or precision of estimates. Our re-examination of the evidence questions the recommendation of the CPG. We believe that the recommendation should have been: "We remain uncertain whether drains in breast reduction have a salutary effect." As such, we recommend that a methodologically robust RCT be conducted to resolve the question of whether drains should be used in breast reduction., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Purpose: Ductal carcinoma in situ (DCIS) of the breast is one of the most common pre-invasive cancers diagnosed in women. Quality of life (QoL) is extremely important to assess in studies including these patients due to the favorable prognosis of the disease. The primary objective of this systematic review was to compile a comprehensive list of QoL issues, all existing QoL assessment tools, and patient-reported outcome measures used to assess DCIS., Methods: A search was conducted on Ovid MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials databases from inception to August 2023, using keywords such as "ductal carcinoma in-situ", "quality of life", and "patient-reported outcomes." QoL issues and QoL tools in primary research studies were extracted., Results: A total of 67 articles identified issues pertaining to patients with DCIS spanning physical, functional, and psychosocial QoL domains. Physical and functional issues observed in patients included pain, fatigue, and impaired sexual functioning. Psychosocial issues such as anxiety, depression, and confusion about one's disease were also common. QoL tools included those that assessed general QoL, breast cancer-specific tools, and issue-specific questionnaires., Conclusion: The current instruments available to assess QoL in patients with DCIS do not comprehensively capture the issues that are pertinent to patients. Thus, the modification of existing tools or the creation of a DCIS-specific QoL tool is recommended to ensure that future research will be sensitive towards challenges faced by patients with DCIS., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Previous literature has produced heterogeneous results on StrataXRT for prevention of acute radiation dermatitis (RD) in breast cancer. This pilot study aimed to assess the feasibility and efficacy of StrataXRT in a cancer center., Methods: The study consisted of five cohorts: (1) patients with large breasts treated with local radiation therapy (RT) either in the supine position or (2) the prone position, (3) patients receiving locoregional breast RT with any breast size, and (4) patients receiving chest wall RT, either locally or (5) locoregionally. The primary endpoint of the study was RD grade as assessed using the Common Terminology Criteria for Adverse Events. Secondary endpoints included incidence of moist desquamation (MD), patient- and clinician-reported skin assessments, patient quality of life as assessed by the Skindex-16, and patient satisfaction. These outcomes were compared with those from a published trial from the same institution assessing standard of care and Mepitel Film (MF) as prevention of breast RD., Results: Forty-five patients receiving RT to the breast or chest wall were enrolled. Two withdrew, leaving 43 evaluable patients. Overall, two (4.7%) patients had grade 3 RD, 14 (32.6%) had grade 2 RD, and 27 (62.8%) had grade 1 RD. Ten patients (23.3%) developed MD during/after RT., Conclusion: StrataXRT is effective in preventing grade 3 RD in patients, and the most promising results were observed within the prone cohort. Further research includes evaluating the efficacy of StrataXRT against the standard of care for the prophylaxis of RD., Trial Registration: The study protocol was registered at ClinicalTrials.gov (identifier: NCT05594498) on October 13, 2022., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Rhinoplasty is one of the most common aesthetic plastic surgery procedures. Complications can lead to both aesthetic and functional impairments. The Consolidated Standards of Reporting Trials (CONSORT) Harms statement was developed to promote improved reporting of harm across randomized controlled trials (RCTs)., Objectives: The aim of this systematic review is to assess harms reporting quality across RCTs on aesthetic rhinoplasty., Methods: A literature search was conducted in Ovid MEDLINE and Embase databases (January 1, 2005 to August 4, 2023). RCTs which compared 2 or more interventions in rhinoplasty with primarily aesthetic indications and assessed patient-important outcomes were included. The reporting quality was assessed by following a 40-item checklist endorsed by the 2022 CONSORT Harms Extension update., Results: A total of 58 RCTs met the inclusion criteria. Fifteen RCTs addressed harms of treatment in some capacity. Overall, the reporting quality across RCTs was poor, with a median CONSORT Harms score of 33% (range, 16%-83%). A reporting adherence of ≥50% was met by only 8 studies. There was no significant difference in reporting adherence between studies based on journal endorsement of CONSORT or industry vs nonindustry funding sources ( P > .05). A high journal impact factor was significantly associated with a higher reporting quality ( P = .044)., Conclusions: CONSORT Harms reporting adherence was poor across the majority of included RCTs. Future trials on aesthetic rhinoplasty should aim to follow the reporting recommendations endorsed by the CONSORT Harms statement to increase transparency and minimize heterogeneity in harms reporting across studies., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society.)

Introduction: Given the aging population, plastic surgeons are increasingly faced with the challenge of balancing procedural bleeding risk with thromboembolic risk in patients receiving antithrombotic therapies undergoing elective procedures. Guideline recommendations remain unclear in this population, which contributes to heterogeneity in clinical practices. We present a practical approach that summarizes guideline recommendations to facilitate the perioperative management of patients requiring surgery who are already on antithrombotic agents. Methods: Due to the scarcity of plastic surgery-specific guidelines, recommendations were primarily adapted from the 2022 American College of Chest Physicians guidelines on perioperative management of antithrombotic therapy as they are recognized as authoritative and widely used in clinical practice. Results: A clinical practice conceptual framework was adapted based on preexisting guidelines, dividing decision-making into 3 steps: (1) assessing the procedural bleeding risk; (2) assessing the patients' thromboembolic risk; and (3) determining appropriate management according to antithrombotic agent type. Specific indications are provided for continuing, stopping, and bridging anticoagulants and antiplatelet agents, as well as for consultation with a cardiologist or hematologist. Conclusion: The present framework can be implemented in plastic surgeons' clinical practice to guide the management of patients on antithrombotic therapies, while minimizing nonessential referrals to the thrombosis service. The lack of plastic surgery-specific guidelines on this topic highlights a need for further research to "bootstrap" the risk categorization of plastic surgical procedures and their appropriate perioperative management., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Achilles Thoma is an editor of the book Evidence-Based Surgery: A Guide for Understanding and Interpreting the Surgical Literature and receives royalties from Springer. All other authors have no potential conflicts of interest to declare., (© 2024 The Author(s).)

Background and Purpose: Mepitel Film (MF) has been demonstrated to reduce the severity of radiation dermatitis (RD) in patients receiving breast cancer radiotherapy (RT). The objective of this study was to characterize patient-reported experience with MF use, including its impact on daily activities and wellbeing., Materials and Methods: This single-institution study analyzed anonymized responses to a questionnaire completed by patients who used MF for the prevention of RD during breast cancer RT., Results: Of the 254 patients contacted, 192 patients completed the survey. Most patients disagreed or strongly disagreed that MF limited their ability to perform their daily activities, including household chores (88%, n = 169/191), their ability to work (83%, n = 157/189), or their ability to sleep (85%, n = 163/191). Furthermore, patients agreed or strongly agreed MF was comfortable on their skin (67%, n = 126/189) and protected their skin from rubbing against clothing (86%, n = 161/188). Some patients agreed or strongly agreed that MF affected their ability to shower (31%, n = 50/162), wear bras (28%, n = 51/185), and impacted their level of pruritus (35%, n = 67/189). However, most patients agreed or strongly agreed that their overall experience with MF was positive (92%, n = 173/189) and would recommend MF to a friend undergoing breast cancer RT (88%, n = 166/188)., Conclusion: MF use is associated with positive patient-reported experience during breast RT with minimal impact on daily activities., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: Randomized clinical trials support Mepitel Film (MF) as a prophylactic treatment for radiation dermatitis (RD) in patients undergoing breast radiotherapy. Although several studies have canvassed the opinion of patients on using MF, no such studies have been done to investigate the perception of healthcare professionals (HCPs). The objective of this study was therefore to investigate the perceptions of HCPs on MF as a treatment option for RD., Methods: Anonymized responses to a web-based survey sent to HCPs at a single institution managing patients using MF during breast radiotherapy were analyzed., Results: Of the 28 HCPs contacted, 22 completed the survey, including 6 radiation oncologists (ROs), 11 radiation therapists (RTTs), and 5 nurses. Most HCPs reported MF was better at preventing severe RD than the standard of care and improved radiation-induced skin reactions (n = 20/22, 91%, and n = 19/22, 86%, respectively). MF was recommended for mastectomy patients without reconstruction (n = 15/21, 71%). The majority of HCPs believed that patients' families could be trained to apply and remove MF (n = 19/22, 86%). Many HCPs perceived that implementation of MF would be difficult in terms of maintaining patient flow and wide-scale implementation within their institution (n = 11/22, 50%, and n = 10/22, 46%, respectively). Most HCPs perceived that fewer than 50% of their patients could afford MF if priced at $100 CAD (n = 15/20, 75%)., Conclusion: These findings provide insights into the possibility of MF to be incorporated into standard practice of care for RD. Although most HCPs were satisfied with MF as a prophylactic treatment for RD, there are concerns about its resource-intensive operationalization and financial accessibility to patients. Future research should focus on ways to improve HCP experience with MF and to improve its implementation into clinical settings as standard of care., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: The primary objective is to systematically review primary studies, such as randomized control trials (RCTs), feasibility, exploratory, and case studies; and the secondary objective is to evaluate all secondary articles, such as reviews, guidelines, and editorials, relevant to the use of StrataXRT for the prevention and/or management of radiation dermatitis (RD) in cancer patients., Methods: A literature search was conducted up to February 26, 2023, for articles investigating the use of StrataXRT for the prevention and treatment of RD, in the following databases: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar. The keywords "StrataXRT", "dermatitis", "radiotherapy", and "radiation" were used to identify relevant articles., Results: Twenty-seven articles from 2018 to 2022 were identified to fulfill the inclusion criteria of this review, of which nine are primary studies and 18 are secondary papers. Significant heterogeneity was observed in the current literature studying the effects of StrataXRT, making it difficult to make cross-trial comparisons. There is a suggestion of the efficacy of StrataXRT in the prevention and treatment of RD., Conclusion: The findings of this review recommend further adequately powered RCTs with robust methodology including patient and clinician assessments to determine the efficacy of StrataXRT in preventing and treating RD. This is essential to improve the quality of life of patients and identify which groups of patients would benefit most from StrataXRT., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: The then-test, also known as the retrospective pre- and post-test design method, is a measurement used to evaluate response shift. The method requires patients to assess their previous health-related quality of life (HRQoL) and provide a retrospective judgement based on their current perspectives. The then-test, however, has been criticized for its reliability and validity. The objective of this systematic review is to summarize the current literature for the use of the then-test for evaluating HRQoL in cancer patients and account for potential response shift effects., Methods: A literature search was conducted in May 2022 using MEDLINE, PubMed, and PsychINFO dated from 2005 to the time of the search. Studies were included if they (I) used the then-test and (II) involved a population of cancer patients (any cancer site)., Results: The literature search resulted in 16 studies, published between 2005 and 2020. All studies used the then-test to detect response shifts. The EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires were the most common assessments used to evaluate HRQoL. Of the 16 articles, 5 exclusively reported on breast cancer, 5 reported on prostate cancer, and the remaining included all cancer sites. Most studies looked at patients undergoing a combination of chemotherapy, radiotherapy, and hormonal therapy. The mean differences between the retrospective assessment at both 3 and 6 months were significant for various quality of life (QoL) dimensions. Patients in some studies recalled their pretreatment HRQoL (then-score) as better than the pretreatment baseline scores and others reported them as worse, both confirming the existence of a response shift., Conclusions: Our review demonstrates that the then-test measurement tool has been commonly used for the detection of response shift. Newer measures for response shift have become more accepted; the then-test, if used, should be used with caution considering its limitations and the emergence of more advanced methods.

Purpose: This systematic review and meta-analysis evaluates the efficacy of Mepitel Film in preventing acute radiation dermatitis (RD) in patients with head and neck cancer (HNC) across randomized controlled trials (RCTs)., Methods: Embase, MEDLINE, and Cochrane Central Register of Controlled Trials were searched on 5 March 2023 to identify relevant RCTs. RD assessment tools and outcomes were compared across studies. Pooled effect sizes and 95% confidence intervals (CI) were estimated based on random-effects analysis using RevMan 5.4., Results: Three RCTs conducted between 2018 and 2020 were included. Mepitel Film decreased RD severity when compared to Sorbolene or Biafine but not when compared to mometasone. A per-protocol analysis of two of the trials revealed that, overall, Mepitel Film significantly reduced the incidence of grade 2-3 RD (odds ratio (OR), 0.24; 95% CI, 0.09-0.65; p = 0.005) and moist desquamation (OR, 0.21; 95% CI, 0.10-0.46; p < 0.0001) and decreased average patient, researcher, and combined components of the Radiation-Induced Skin Reaction Assessment Scale (the standardized mean difference (SMD) for patient ratings, - 2.56; 95% CI, - 3.15 to - 1.96, p < 0.00001; SMD for researcher ratings, - 3.47; 95% CI, - 6.63 to - 0.31, p = 0.03; SMD for combined scores, - 3.68; 95% CI, - 6.43 to - 0.92, p = 0.009). Noted issues with Mepitel Film included itchiness and poor adherence., Conclusion: While there were discrepancies across studies, Mepitel Film demonstrated a decrease in the incidence of grade 2-3 RD and moist desquamation. These findings emphasize the need for further examining Mepitel Film's efficacy across diverse patient groups and the importance of standardizing RD severity assessment methodologies and control arms., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: This systematic review and meta-analysis aimed to evaluate the efficacy of Mepitel film in preventing or treating acute radiation dermatitis (RD) in patients with breast cancer in randomized controlled trials (RCTs)., Methods: Embase, APA PsychInfo, Journals@Ovid Full Text, Ovid MEDLINE, PubMed, and Cochrane Trials were searched until December 12, 2022, to identify RCTs on the use of Mepitel film for preventing or treating acute RD from breast cancer radiotherapy. Per-protocol analysis was used to compare outcomes, calculate pooled effect sizes, odds ratio (OR), and 95% confidence intervals (CI), and to create forest plots using random effects analysis in RevMan 5.4., Results: Three RCTs were included in this review. Mepitel film significantly reduced the incidence of grade 3 RD (OR 0.15 95% CI 0.06, 0.37, p<0.0001) and grade 2 or 3 RD (OR 0.16 95% CI 0.04, 0.65, p=0.01) as scored on either the CTCAE or the RTOG scale. Additionally, Mepitel film significantly reduced RISRAS mean scores assessed by patients and combined researcher and patient (standardized mean difference (SMD) -7.59, 95% CI -14.42, -0.76, p=0.03; SMD -15.36, 95% CI -30.01, -0.71 p=0.04) but not the researcher component of the assessment tool (SMD -17.55, 95% CI -36.94, 1.84, p=0.08)., Conclusion: Mepitel film reduced the incidence of acute RD and improved patient-reported outcomes with minimal side effects, the main one being itchiness. Future research should assess the feasibility of Mepitel film with respect to specific patient-reported outcomes such as health-related quality of life issues associated with its use., (© 2023. Crown.)

Purpose: To evaluate the overall efficacy of StrataXRT, a topical gel dressing, in preventing acute radiation dermatitis (RD) in breast cancer patients undergoing radiotherapy (RT)., Methods: A systematic search was conducted on April 25, 2023 in Ovid MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Randomized controlled trials (RCTs) assessing the effectiveness of StrataXRT in preventing acute RD in breast cancer patients undergoing adjuvant RT to the breast or chest wall with or without regional nodes were included. Pooled incidence odds ratio (OR) and 95% confidence interval (CI) were calculated using a random-effects model, with analysis and forest plots generated in RevMan v5.4., Results: The analysis included three RCTs with a total of 189 patients assessed using per-protocol analysis. Two RCTs compared StrataXRT to standard of care, while the third compared it with Mepitel film and was reported separately. In the former RCTs, the odds ratio (OR) for developing acute grade 3 RD favored StrataXRT at 0.05 (95% CI, 0.01-0.22; P < 0.0001). The OR for developing acute grades 2-3 RD was 0.32 (95% CI, 0.03-3.18; P = 0.33). The RCT comparing StrataXRT with Mepitel film showed insignificant ORs for grade 3 and grades 2-3 RD. One RCT reported significantly lower erythema index (P = 0.008) and melanin index (P = 0.015) in StrataXRT patients. The use of StrataXRT did not raise additional safety concerns., Conclusion: StrataXRT may help prevent severe acute RD in breast cancer RT patients. Further high quality, large-scale studies are needed to confirm these findings., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Radiation dermatitis (RD) is a frequently occurring adverse reaction during radiotherapy in cancer patients. While the use of topical corticosteroids (TCs) is common for the treatment of RD, its role in preventing severe reactions remains unclear. This systematic review and meta-analysis aim to evaluate the evidence on the use of TCs as prophylaxis of RD., Methods: A systematic search was conducted using OVID MedLine, Embase, and Cochrane databases (between 1946 and 2023) to identify studies examining TC use in the prevention of severe RD. Statistical analysis was completed using RevMan 5.4 to calculate pooled effect sizes and 95% confidence intervals. Forest plots were then developed using a random effects model., Results: Ten RCTs with a total of 1041 patients met the inclusion criteria. Six studies reported on mometasone furoate (MF) and four studies reported on betamethasone. Both TCs were associated with a significant improvement in the prevention of moist desquamation [OR = 0.34, 95% CI [0.25, 0.47], p < 0.00001], but betamethasone was found to be more effective than MF [OR = 0.29, 95% CI [0.18, 0.46], p < 0.00001 and OR = 0.39, 95% CI [0.25, 0.61], p < 0.0001, respectively]. A similar finding was seen in reducing the development of grade 2 or higher RD according to the Radiation Therapy Oncology Group scale., Conclusions: The current evidence supports the use of TCs in preventing severe reactions of RD. Both MF and betamethasone were found to be effective; however, betamethasone, a higher potency TC, is more effective despite MF being more commonly reported in literature., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background and Purpose: As breast cancer radiotherapy (RT) has been shown to give rise to adverse pulmonary outcomes, such as radiation pneumonitis, trends in patient-reported shortness of breath (SOB) associated with RT were investigated. Adjuvant RT is commonly administered for local and/or regional control of breast cancer and was therefore included., Methods: The Edmonton Symptom Assessment System (ESAS) was used to observe changes in SOB during RT, up to 6 weeks after RT completion, and one to three months post-RT. Patients with at least one completed ESAS were included in the analysis. Generalized linear regression analysis was performed to identify associations between demographic factors and SOB., Results: A total of 781 patients were included in the analysis. There was a significant association between ESAS SOB scores and adjuvant chemotherapy when compared to neoadjuvant chemotherapy (p=0.0012). Meanwhile, loco-regional RT had no significant impact on ESAS SOB scores in comparison to local RT. SOB scores were stable over time (p>0.05) from baseline to follow-up appointments., Conclusion: The findings of this study suggest that RT was not associated with changes in SOB from baseline to 3 months post-RT. However, patients who underwent adjuvant chemotherapy reported significant higher SOB scores over time. Additional research is recommended to analyze the lasting effects of adjuvant breast cancer RT on SOB during physical activity., (Copyright © 2023. Published by Elsevier Inc.)

Background and Objective: The 30-day expected mortality rate is frequently used as a metric to determine which patients benefit from palliative radiation treatment (RT). We conducted a narrative review to examine whether its use as a metric might be appropriate for patient selection., Methods: A literature review was conducted to identify relevant studies that highlight the benefits of palliative RT in timely symptom management among patients with a poor performance status, the accuracy of predicting survival near the end of life and ways to speed up the process of RT administration through rapid response clinics., Key Content and Findings: Several trials have demonstrated substantial response rates for pain and/or bleeding by four weeks and sometimes within the first two weeks after RT. Models of patient survival have limited accuracy, particularly for predicting whether patients will die within the next 30 days. Dedicated Rapid Access Palliative RT (RAPRT) clinics, in which patients are assessed, simulated and treated on the same day, reduce the number of patient visits to the radiation oncology department and hence the burden on the patient as well as costs., Conclusions: Single-fraction palliative RT should be offered to eligible patients if they are able to attend treatment and could potentially benefit from symptom palliation, irrespective of predicted life expectancy. We discourage the routine use of the 30-day mortality as the only metric to decide whether to offer RT. More common implementation of RAPRT clinics could result in a significant benefit for patients of all life expectancies, but particularly those having short ones.

Purpose: This systematic review and meta-analysis aims to evaluate the effects of washing in patients receiving radiotherapy (RT) on radiation dermatitis (RD) severity., Methods: A literature search was performed using Ovid MEDLINE, Embase, and Cochrane databases between January 1, 1946, and January 31, 2023. Four randomized controlled trials (RCTs) studying the effects of washing with or without soap on RD were identified. A meta-analysis was conducted for clinician-reported outcomes using RevMan 5.4 and a narrative synthesis for patient-reported outcomes due to a lack of reported data amenable to quantitative comparison in accordance with the Synthesis Without Meta-analysis (SWiM) guidelines. The Cochrane Risk of bias (RoB2) and Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria were used to assess risk of bias and certainty of evidence, respectively., Results: Two RCTs met the inclusion criteria for meta-analysis. Washing with or without soap significantly reduced the incidence of severe RD (OR: 0.32, 95% CI: 0.19-0.55, p < 0.01) and moist desquamation (OR: 0.25, 95% CI: 0.12-0.52, p < 0.01). Two of four trials found an association between washing and reduced itching score (p = 0.38). Pain score was not found to be significantly different with or without washing in any of the four studies (p = 0.07). The two studies that assessed burn scores did not detect any difference between the washing group versus no washing group (p = 0.25). Washing was associated with improved quality of life (QoL) measures in one study., Conclusion: Washing with or without soap during RT resulted in less severe RD and less moist desquamation. Given the QoL benefits of washing, it should be advocated as part of routine skin care during RT., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background and Purpose: Regional nodal irradiation (RNI) is commonly administered in patients with breast cancer with node-positive disease to prevent cancer recurrence. The purpose of this study is to identify whether RNI is associated with greater acute symptom burden from baseline to 1 to 3 months post completion of radiotherapy (RT) when compared to localized RT., Materials and Methods: Patient and treatment characteristics were collected prospectively for breast cancer patients with and without RNI from February 2018 to September 2020. The Edmonton Symptom Assessment System (ESAS) and Patient-Reported Functional Status (PRFS) tool were completed by patients at baseline, weekly during RT, and at a 1- to 3-month follow-up visit. The Wilcoxon rank-sum or Fisher exact tests were used to compare variables between patients with or without RNI., Results: A total of 781 patients were included in the analysis. Baseline symptom reporting was similar between cohorts, with the exception of PRFS scores (p = 0.0023), which were worse in patients receiving RNI. Across all time points, differences in outcomes between cohorts were minimal, except for lack of appetite (p = 0.03) and PRFS scores (p = 0.049), which were significantly aggravated in patients treated with RNI., Conclusion: There is insufficient evidence to suggest that RNI is associated with greater symptom burden as assessed with the ESAS. Further research should be conducted over a longer time period to determine the impact of late effects of RNI on patient-reported symptoms., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Over several decades, research on the prevention and management of acute radiation dermatitis (RD) has continued to emerge, yet there remains no "gold standard" treatment for RD care. Recent guidelines on RD prevention and management were published in 2022 by the Oncodermatology Study Group of the Multinational Association of Supportive Care in Cancer (MASCC). As part of this guideline process, a collaborative effort was undertaken by international RD experts to quantitatively compare commonly studied RD skin interventions through meta-analyses and discern superiority of interventional treatments over another intervention, standard-of-care, or placebo in RD prevention and management. This paper summarizes the materials and methodology used in a set of meta-analysis studies that supplement the 2022 MASCC Clinical Practice Guidelines on RD Prevention and Management., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Acute radiation dermatitis is a frequent adverse effect of radiotherapy, but standardisation of care for acute radiation dermatitis is lacking. Due to the conflicting evidence and variability in current guidelines, a four-round Delphi consensus process was used to compile opinions of 42 international experts on care for people with acute radiation dermatitis on the basis of the evidence in existing medical literature. Interventions for acute radiation dermatitis prevention or management that reached at least 75% consensus were recommended for clinical use. Six interventions could be recommended for the prevention of acute radiation dermatitis: photobiomodulation therapy and Mepitel film in people with breast cancer, Hydrofilm, mometasone, betamethasone, and olive oil. Mepilex Lite dressings were recommended for the management of acute radiation dermatitis. Most interventions were not recommended due to insufficient evidence, conflicting evidence, or lack of consensus to support use, suggesting a need for further research. Clinicians can consider implementing recommended interventions in their practice to prevent and manage acute radiation dermatitis until additional evidence becomes available., Competing Interests: Declaration of interests AM declares National Institutes of Health–National Cancer Institute Cancer Center Support Grant (P30-CA008748) funding; Incyte and Amryt Pharma research funding; UpToDate royalty payments; and consulting fees from Alira Health, Protagonist Therapeutics, and Janssen. AF-M declares consulting fees from ISDIN, Cantabria Labs, and Shook, Hardy, and Bacon; payment or honoraria from L'Oréal Spain; non-financial support from Pierre Fabre; and payment for expert testimony from Shook, Hardy, and Bacon, who serves Sanofi. BK declares consulting fees received from Novartis and Oncoderm, a co-chair position for the Cal Derm Norcal conference, and non-financial consultancy for Happy2ndBirthday. CMR-H is the chief executive officer for Sancturay Skin Care for Hope (skin product line). EC conducted a clinical trial and received materials free of cost from Mölnlycke Health Care. JR received research grants from Kom op Tegen Kaker and Limburgs Kankerfonds. JRW declares Biomedical Advanced Research and Development Authority funding for a clinical trial on the safety of Silverlon dressing for radiation dermatitis and UpToDate coauthor royalties. NAI received support for attending the Italian Association of Radiation Oncology Congress 2021. TB received a travel grant from the European Organisation for Research and Treatment of Cancer Quality of Life Group (autumn, 2022). RM received payments from the American Society for Radiation Oncology for a leadership or fiduciary role. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Acute radiation dermatitis (ARD) commonly develops in cancer patients undergoing radiotherapy and is often characterized by erythema, desquamation, and pain. A systematic review was conducted to summarize the current evidence on interventions for the prevention and management of ARD. Databases were searched from 1946 to September 2020 to identify all original studies that evaluated an intervention for the prevention or management of ARD, with an updated search conducted in January 2023. A total of 235 original studies were included in this review, including 149 randomized controlled trials (RCTs). Most interventions could not be recommended due to a low quality of evidence, lack of supporting evidence, or conflicting findings across multiple trials. Photobiomodulation therapy, Mepitel® film, mometasone furoate, betamethasone, olive oil, and oral enzyme mixtures showed promising results across multiple RCTs. Recommendations could not be made solely based on the published evidence due to limited high-quality evidence. As such, Delphi consensus recommendations will be reported in a separate publication., Competing Interests: Julie Ryan Wolf declares BARDA funding for clinical trial for safety of Silverlon dressing for radiation dermatitis and UpToDate coauthor royalties. Tara Behroozian received a travel grant from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (Fall 2022). Edward Chow conducted a clinical trial and received materials free of cost from Mölnlycke Health Care. All other authors declare that they have no conflict of interest., (© 2023 The Authors.)

Background and Purpose: Patients undergoing radiotherapy (RT) for breast cancer may receive adjuvant or neoadjuvant chemotherapy prior to the initiation of RT treatment. In the present study, baseline Edmonton Symptom Assessment System (ESAS) scores of patients who received neoadjuvant and adjuvant chemotherapy were collected prior to RT and compared to assess the association of each chemotherapy intent with pre-RT symptom burden., Material and Methods: The ESAS and Patient-Reported Functional Status (PRFS) tools were used to collect patient-reported symptoms at baseline. Patient and treatment-related factors were collected prospectively from February 2018 to September 2020. Univariate general linear regression analysis was applied to compare baseline scores between adjuvant and neoadjuvant chemotherapy patients., Results: A total of 338 patients were included for analysis. Comparison of baseline ESAS scores revealed that patients who received adjuvant chemotherapy were more likely to report higher scores, reflecting higher symptom burden, compared to patients receiving neoadjuvant chemotherapy, including tiredness (p = 0.005), lack of appetite (p = 0.0005), shortness of breath (p < 0.0001), and PRFS (p = 0.012)., Conclusion: This study suggests an association between patients who have received adjuvant chemotherapy for breast cancer and higher RT baseline ESAS scores when compared to patients who received neoadjuvant chemotherapy. Due to these findings, considerations should be made by healthcare providers of the symptom burden during RT for patients who receive adjuvant chemotherapy., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Introduction: Self-administered methoxyflurane, also known as Penthrox, at a sub-anesthetic dose is a short-term, fast-acting, and safe analgesic that may provide suitable pain relief for cancer patients. This review aims to compile the existing evidence on methoxyflurane and its efficacy in reducing pain during cancer-related procedures., Methods: A literature search was conducted through OVID Medline and Embase. The search was limited to articles published between 2012 and 2021 and studies were included if they assessed the efficacy of methoxyflurane to reduce pain in cancer-related procedures. All types of cancer were included., Results: The literature search yielded seven studies published between 2012 and 2021. The studies analyzed assessed methoxyflurane use in prostate biopsy, colonoscopy, removal of brachytherapy rods, and bone marrow biopsy. Various research designs were employed, including three randomized controlled trials, two prospective observational studies, one retrospective, and one non-randomized controlled trial. In all, methoxyflurane has a demonstrated ability to reduce pain in these procedures., Conclusion: In the limited studies available in evaluating the efficacy of methoxyflurane for reducing procedural pain during cancer-related procedures, all have demonstrated clinical equivalency or superiority. Pain relief appears to be equivalent however methoxyflurane overcomes the standard limitations of respiratory sedation and has demonstrated quicker procedural recovery times than traditional sedation methods. The accumulated data to date supports the use of methoxyflurane which can supplement or supplant current methods of analgesia in cancer-related procedures., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Approximately 95% of patients undergoing radiotherapy (RT) experience radiation dermatitis (RD). Evidence has suggested that photobiomodulation therapy (PBMT) can stimulate skin renewal and minimize RD. The aim of the present paper was to investigate the efficacy of PBMT in RD prevention through a comprehensive literature review., Methods: A literature search of Ovid MEDLINE, Embase, and Cochrane databases was conducted from 1980 to March 2021 to identify RCT on the use of PBMT for RD prevention. Forest plots were developed using RevMan software to quantitatively compare data between studies., Results: Five papers were identified: four in breast and one in head and neck cancer patients. Patients receiving PBMT experienced less severe RD than the control groups after 40 Gray (Gy) of RT (grade 3 toxicity: Odds Ratio (OR): 0.57, 95% CI 0.14-2.22, p = 0.42) and at the end of RT (grade 0 + 1 vs. 2 + 3 toxicity: OR: 0.28, 95% CI 0.15-0.53, p < 0.0001). RT interruptions due to RD severity were more frequent in the control group (OR: 0.81, 95% CI 0.10-6.58, p = 0.85)., Conclusion: Preventive PBMT may be protective against the development of severe grades of RD and reduce the frequency of RT interruptions. Larger sample sizes and other cancer sites at-risk of RD should be evaluated in future studies to confirm the true efficacy of PBMT, also in preventing the onset of RD and to finalize a standardized protocol to optimize the technique. At present, starting PBMT when RT starts is recommendable, as well as performing 2 to 3 laser sessions weekly., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: This systematic review and meta-analysis aimed to evaluate the efficacy of barrier films and dressings in preventing acute radiation dermatitis (RD)., Methods: OVID Medline, Embase, and Cochrane databases were searched from 1946 to September 2020 to identify randomized controlled trials on the use of barrier films or dressings to prevent RD. For comparable outcomes between studies, pooled effect sizes and 95% confidence intervals (CI) were calculated using the random effects analysis in RevMan 5.4., Results: Fourteen and 11 studies were included in the qualitative and quantitative analyses, respectively. Five types of barrier films used for RD were identified: Hydrofilm, StrataXRT®, Mepitel® Film, 3 M™ Cavilon™ No-Sting Barrier Film, and silver leaf nylon dressing. Hydrofilm and Mepitel Film significantly reduced the development of RD grade ≥ 2 in breast and head and neck cancer patients (RR 0.32, 95%CI 0.19, 0.56, p < 0.0001; RR 0.21, 95%CI 0.05, 0.89, p = 0.03, resp.). Moreover, Hydrofilm had a beneficial effect on patient-reported outcomes (PROs) (SMD -0.75, 95%CI -1.2, -0.29, p = 0.001). The meta-analyses on the other barrier films did not show any significant effect., Conclusion: This review and meta-analysis demonstrated that Hydrofilm and Mepitel Film could effectively reduce RD severity and improve PROs. The evidence is generally weak for all the studies on barrier films and dressings due to a limited study number, high risk of bias, small sample sizes, and minimal comparable outcome measures. It's potential has been proven, but future research in this field is recommended to confirm the efficacy of these products and assess real-world feasibility., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Radiation dermatitis (RD) is a common side effect of radiation therapy, affecting a majority of breast and head and neck cancer patients with a negative impact on quality of life. Currently, no consensus exists regarding the prevention of RD., Methods: PubMed, Embase and Cochrane databases (1946 to December 2022) were searched using PRISMA guidelines to identify randomized controlled trials (RCTs) that investigated the use of topical non-steroidal agents in the prevention of RD in patients undergoing radiotherapy., Results: A total of six RCTs were included, comprising 627 patients. Among the topical non-steroidal agents analyzed, only the use of Biafine® in breast cancer patients was significant in preventing grade 4 and 3 + RD as classified by the Radiation Therapy Oncology group (RTOG) scale (OR = 0.07, 95% CI 0.01-0.63, p = 0.02, and OR 0.11, 95% CI 0.03-0.41, p < 0.01, respectively). The remaining agents (trolamine alone and hyaluronic acid/hyaluronan) did not significantly prevent the occurrence of RD., Conclusion: The results of this systematic review and meta-analysis indicate that Biafine® can prevent grade 3 + RD in breast cancer patients. The use of trolamine and hyaluronic acid does not significantly affect the incidence of RD., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: While some authors have investigated the impact of antiperspirant /deodorant on the development of acute radiation dermatitis (RD) among patients undergoing radiotherapy (RT) for breast cancer, recommendations supporting the use of antiperspirant/deodorant during breast RT remain highly variable. This systematic review and meta-analysis aims to evaluate the evidence investigating the effect of antiperspirant/deodorant on the development of acute RD during post-operative breast RT., Methods: A literature search has been performed using OVID MedLine, Embase, and Cochrane databases (1946 to September 2020) to identify randomized controlled trials (RCTs) that have investigated deodorant/antiperspirant use during RT. The meta-analysis was conducted using RevMan 5.4 to calculate pooled effect sizes and 95% confidence intervals (CI)., Results: Five RCTs met the inclusion criteria. The use of antiperspirant/deodorant did not significantly affect the incidence of grade (G) 1 + RD (OR 0.81, 95% CI 0.54-1.21, p = 0.31). Prohibition of deodorant use did not significantly prevent the occurrence of G2 + acute RD (OR 0.90, 95%, CI 0.65-1.25, p = 0.53). No significant effect was reported in preventing G3 RD between the antiperspirant/deodorant and control groups (OR 0.54, 95%, CI 0.26-1.12, p = 0.10). There was no significant difference in pruritus and pain between patients undergoing skin care protocols with or without antiperspirant/deodorant (OR 0.73, 95% CI 0.29, 1.81, p = 0.50, and OR 1.05, 95% CI 0.43-2.52, p = 0.92, respectively)., Conclusions: The use of antiperspirant/deodorant during breast RT does not significantly affect the incidence of acute RD, pruritus, and pain. As such, the current evidence does not support recommendation against antiperspirant/deodorant use during RT., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: This systematic review and meta-analysis aimed to evaluate the available literature describing the efficacy of natural and miscellaneous agents in preventing acute radiation dermatitis (RD) in cancer patients., Methods: OVID MedLine, Embase, and Cochrane literature databases were searched from 1946 to January 2023 for randomized controlled trials studying the use of natural and miscellaneous agents to prevent RD. RevMan 5.4 was used for the meta-analysis to calculate the pooled effect sizes and 95% confidence intervals (CI) using the random effects analysis., Results: For the systematic review and meta-analysis, 19 and 16 studies were included, respectively. Of the five studied natural products (aloe vera, oral enzymes, olive oil, calendula, and curcumin), only oral enzymes and olive oil significantly reduced the incidence of Radiation Therapy Oncology Group grade 2 + (RR: 0.42, 95%CI 0.30-0.58, p < 0.00001, RR: 0.66, 95% CI 0.51-0.85, p = 0.001, resp.). The oral enzymes also reduced the grade 3 + RD incidence (RR: 0.18, 95%CI 0.06-0.55, p = 0.003). The other agents demonstrated no significant effect., Conclusion: This review and meta-analysis on natural and miscellaneous agents in preventing RD in cancer patients demonstrated that oral enzymes and olive oil prevented RD severity. However, evidence supporting natural agents to prevent RD is inconsistent, mainly because of low studies numbers, low-quality study designs, and small sample sizes. Therefore, concrete conclusions cannot be made. Research on (new) natural or miscellaneous agents should focus on a randomized controlled double-blinded study design with a large patient population, a higher consistency in research methods, and clinician- and patient-reported outcomes., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Radiation dermatitis (RD) is common in patients undergoing breast radiotherapy. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. We aimed to conduct a confirmatory randomized controlled trial in patients at risk of RD., Methods: Patients were randomly assigned to receive MF or standard care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type, dose fractionation, and administration of boost/bolus. The primary end point was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events v5.0. Secondary end points included patient- and clinician-reported outcomes., Results: Between January 2020 and May 2022, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared with standard care (n = 39/251, 15.5%; 95% CI, 11.3 to 20.6% v n = 57/125, 45.6%; 95% CI, 36.7 to 54.8% respectively, odds ratio (OR): 0.20, P < .0001). Benefits of MF remained significant in patients who developed G 3 RD (n = 7, 2.8%; 95% CI, 1.1 to 5.7% v n = 17, 13.6%; 95% CI, 8.1 to 20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9 to 12.0% v n = 24, 19.2%; 95% CI, 12.7 to 27.1%, OR: 0.36). When evaluating the combined patient and health care provider score using Radiation-Induced Skin Reaction Assessment Scale, the MF arm had significantly lower scores ( P < .0001). Individual items on the Radiation-Induced Skin Reaction Assessment Scale also favored the MF for both patient- and clinician-reported outcomes. Blistering/peeling, erythema, pigmentation, and edema were significantly reduced in the MF arm. Three patients removed the film prematurely because of rash (n = 2) and excessive pruritus (n = 1)., Conclusion: MF significantly reduces RD in patients undergoing breast radiotherapy.

Supportive oncodermatology is a burgeoning new field within dermatology tasked with caring for the unique dermatologic needs of patients with cancer. Patients with dermatologic adverse events (dAEs) from localized and systemic anti-cancer therapies commonly experience significant distress and reduced health-related quality of life (HRQoL). Emerging dAEs is often overlooked by clinicians and researchers, despite their considerable impacts on treatment completion and patient self-esteem. Specific HRQoL issues experienced by cancer patients with dAEs include psychosocial distress and treatment interruption or cessation. Existing HRQoL assessment indices unfortunately fall short when assessing HRQoL in patients with dAEs from anti-cancer therapies due to the lack of specificity to patients' symptoms and inability to fully encompass the unique needs of this population. Additionally, the variability in HRQoL assessments across studies is substantial, suggesting the need for a standardized HRQoL measure. Here, we review the burden of dAEs and the existing validated tools used to measure them, while outlining strategies for modification to achieve optimal HRQoL assessment in patients with dAEs from anti-cancer therapies and address the HRQoL gap in supportive oncodermatology. Amongst the current tools, Skindex-16 most closely addresses the required skin-specific HRQoL metrics, but still lacks a few key cancer-specific measures. Other general HRQoL tools are well-tailored to cancer patients, but lack skin-specific questions., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Radiation dermatitis (RD) is a common side effect of radiation therapy (RT). While many different treatment strategies are currently used to address RD, there is a lack of consensus and RD prophylaxis and management guidelines have remained largely unchanged over the last 10 years. This review aims to formulate unambiguous supportive care interventions by comparing RD clinical practice guidelines published between 2010 and 2021 by several organizations: Multinational Association for Supportive Care in Cancer (MASCC), British Columbia Cancer Agency (BCCA), Cancer Care Manitoba (CCMB), Oncology Nursing Society (ONS), Society and College of Radiographers (SCoR), and International Society of Nurses in Cancer Care (ISNCC)., Methods: Areas of agreement and discordance were assessed among the MASCC, BCCA, CCMB, ONS, SCoR, and ISNCC guidelines., Results: Treatment recommendations across guidelines for acute RD and chronic RT-induced skin toxicities have been summarized. The strongest agreement among the guidelines exists for the use of topical corticosteroids, silver sulfadiazine, washing, and deodorant. All guidelines recommend the use of topical corticosteroids, and washing with water and soap is consistently supported. There is minimal consensus on an optimal dressing or barrier film for RD prophylaxis or management. MASCC weakly recommends prophylactic use of silver sulfadiazine to reduce RD, while BCCA, CCMB, and SCoR recommend its use upon signs of infection. MASCC and CCMB recommend the use of a long-pulsed dye laser to manage telangiectasia, a late effect of RT., Conclusions: Given the extent of discordance among guideline recommendations, further research is recommended to establish optimal treatments for RD prophylaxis and management., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Radiation dermatitis (RD) is a side effect experienced by many patients undergoing radiotherapy (RT) for breast cancer. In the present study, the Edmonton Symptom Assessment System (ESAS), a validated patient-reported symptom screening tool, was used to determine the impacts of RT-induced skin outcomes on ESAS items. Patient- and treatment-related factors and skin treatments to manage RD symptoms, were assessed for association with ESAS scores., Methods: Patient and treatment characteristics were collected retrospectively for breast cancer patients treated with adjuvant RT between December 2013 and November 2015. Prospective data was collected through clinician-reported surveys. Linear regression analyses were performed to detect the relationship between patient-reported ESAS scores and clinician-reported RD symptoms., Results: A total of 857 patients were included in the analysis. Moderate to severe scores were commonly reported for fatigue (n = 412, 48%), wellbeing (n = 386, 45%) and anxiety (n = 266, 31%). Oral analgesic use was associated with ESAS fatigue, drowsiness, pain, nausea, lack of appetite, shortness of breath, and wellbeing (P < .05), while dressings were only associated with anxiety (P = .02). No RD symptoms were found to be significantly associated with any ESAS items., Conclusions: The ESAS accurately reflects symptoms of fatigue, anxiety, and wellbeing for breast cancer patients undergoing RT. Our study, however, found no association between ESAS scores and RD severity, which may reflect the shortcomings of the ESAS in assessing symptom burden. Further research is necessary to warrant the development of a new site-specific symptom screening tool for use in RT for breast cancer., (Copyright © 2021. Published by Elsevier Inc.)

Background: Synchronous bilateral breast cancer (SBBC) is rare and there is little evidence describing organs at risk (OAR) and limits to the heart and lungs caused by radiotherapy (RT). Quantifying mean heart dose (MHD) and mean lung dose (MLD) from RT in this patient cohort may lead to better understanding of doses to OAR and resultant effects on clinical outcomes. The primary objective was to assess median MHD and MLD in SBBC, while secondary aims included analyses of 1) factors associated with MHD and MLD, 2) V5 and V20 values and 3) factors associated with clinical outcomes., Methods: Patients planned for adjuvant bilateral whole breast/chest wall (WB) RT from a single institution treated in 2011-2018 were included. Median MHD and MLD (Gy) were stratified by hypofractionated (42.56 Gy/16 fractions, HFRT) and conventional fractionation (50 Gy/ 25 fractions, CFRT) and summarized separately based on the following treatments: 1) locoregional RT, WB tangential RT either 2) no boost 3) sequential boost or 4) simultaneous integrated boost. MHD, MLD, lung V5 and V20 values, and demographics were collected. Linear regression analyses identified factors associated with MHD and MLD and factors associated with clinical outcomes., Results: A total of 88 patients were included. The median MHD for HFRT and CFRT was 1.99 Gy and 2.94 Gy, respectively. The median MLD for HFRT and CFRT was 6.00 Gy and 10.08 Gy, respectively. MHD and MLD were significantly associated with the occurrence of a cardiac or pulmonary event post-radiation. Patients who had a mastectomy or tumoral muscle involvement were more likely to develop a local recurrence, metastasis or new primary while patients who had a lumpectomy or tumor with a positive estrogen receptor status were less likely to experience these events., Conclusions: Further investigation should be conducted to identify SBBC RT techniques that mitigate dose to OARs to improve clinical outcomes in bilateral breast patients., (Copyright © 2021. Published by Elsevier Inc.)

Background and Purpose: Breast cancer patients frequently develop radiation dermatitis (RD) when undergoing post-operative radiation therapy (RT). Traditional RD assessment methods measure clinician-reported outcomes (CROs), but patient-reported outcomes (PROs) have gained recent popularity. The purpose of this prospective analysis was to compare PROs with CROs of breast RD., Materials and Methods: Demographic and treatment characteristics were prospectively collected for patients receiving post-operative RT between February 2018 to September 2020. Patients and clinicians completed a skin symptom assessment at baseline, weekly during RT, and at a one- to three-month follow-up visit. Skin treatments used by patients were collected. Concordance between each PRO and CRO was determined using percent concordance and concordance index (C-statistic) by logistic regression analysis., Results: A total of 777 patients were included in the present study. All skin symptom assessment items were significantly underreported by clinicians in comparison to patients (p < 0.0001), with a low to moderate level of concordance (C-statistic range: 0.58-0.70; percent concordance range: 29-50%). The majority of patients used moisturizing creams as a prophylactic measure (65.1%), as per institutional guidelines., Conclusion: There were significant discrepancies between PROs and CROs when assessing breast RD. CROs alone are insufficient in measuring RD as they fail to capture the impact on patient quality of life. The study findings highlight the need for improved RD symptom assessment and support the development of a new tool with both patient and clinician components., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Purpose: This review aimed to assess the quality and efficacy of tools currently used in breast cancer patients to score radiation dermatitis (RD), a common debilitating side effect of radiotherapy (RT)., Methods: A search was conducted through Ovid Medline, Embase, and Cochrane Central Register of Controlled Trials databases on 14 February 2020. English articles that evaluated an instrument's use in assessing RD among breast cancer patients receiving external beam RT were included. Studies that reported on the reliability, validity, or concordance of items between assessment tools were included in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria., Results: Twelve studies were included in this review, with a total of 13 skin toxicity assessment tools discussed. Tools that assessed clinician-reported outcomes (CROs) mostly reported moderate correlation with biophysical parameter (BP) measurements and low correlation with patient-reported outcomes (PROs). Traditionally used CRO scoring tools demonstrated moderate inter-rater reliability between clinicians, likely due to the subjective nature of items on the grading scales. Most commonly used tools were found to be either insufficient or indeterminate in their measurement properties., Conclusions: Current standardized tools that measure CROs are subject to clinician interpretation and fail to represent the patient experience. Tools designed to assess PROs are promising in their assessments of the impact of RT on patient quality of life; however, most PRO tools are generic to all skin conditions and require further validation for use in breast cancer. Among tools that measure CROs, PROs, and BPs, there is insufficient evidence on their measurement properties to establish a "gold standard" for the assessment of RD in breast cancer patients.

Purpose: The Edmonton Symptom Assessment Scale (ESAS) is a validated tool used in patients with varied cancer diagnoses to measure patient symptoms. The present manuscript will review the literature assessing the ability of the ESAS to predict patient-related outcomes in breast cancer patients., Methods: A literature search was conducted of Cochrane Central Register of Controlled Trials databases, Ovid MEDLINE, and Embase for English articles that investigated the use of predictive modelling with the ESAS in the breast cancer population. Study type, publication year, sample size, patient demographics, predicted outcomes, and strongest predictive factors/symptoms were summarized for each study., Results: A total of nine articles were included in this review. Five articles used the ESAS in predictive models to determine patient time to death. ESAS was also used to predict emergency department visits, determine symptoms associated with decreased quality of life, and generate a Health Utility Score. Lack of appetite was the most common ESAS symptom, as it was reported in five studies to be associated with decreased survival. In four of the nine articles, an additional survey investigating physical functioning was used in combination with ESAS to strengthen the predictive models., Conclusions: Included studies support the use of ESAS in predictive models, particularly for predicting survival. Using the ESAS as a predictive tool allows for more accurate time to death predictions, potentially improving symptom management and preventing overtreatment of palliative patients near the end of life.

Purpose: Radiation dermatitis (RD) is a side effect that frequently arises during radiotherapy (RT) in breast cancer patients. The present study investigates possible predictive factors of RD, as well as the use of skin treatments to manage symptoms., Methods: Demographic and treatment characteristics were collected retrospectively, while skin symptoms and treatments were collected prospectively for patients who received adjuvant RT between December 2013 and November 2015. Patients were seen weekly by clinicians throughout treatment, during which a clinician-reported survey was completed on RD symptoms and skin treatments. Possible predictive factors were correlated with skin outcomes through a univariate ordinal logistic regression analysis., Results: A total of 1093 patients were included in this analysis. Predictive factors for erythema included dose fractionation (p<0.0001), tissue volume irradiated by tangential fields (p = 0.01), and administration of a boost (p = 0.005). High BMI (≥30 kg/m 2 ) (p = 0.0004) and boost (p = 0.02) were predictive of edema. A dose of 50 Gy/25 (p<0.0001) and a high irradiated tissue volume (p = 0.0001) were predictive of desquamation. A dose of 50 Gy/25 (p = 0.0005) and high BMI (p = 0.02) were predictors of pain. Bolus use was the only factor associated with bleeding (p = 0.02). Patients who developed desquamation were likely to receive corticosteroids/antihistamines (p<0.0001), topical antibiotics/antifungals (p<0.001), and dressings (p<0.0001)., Conclusion: The findings of this study provide evidence of potential predictors of RD and methods of symptom management based on symptom severity. Prevention of RD is needed among high-risk groups, such as patients with a high BMI or receiving a standard fractionation, boost, or bolus., (Copyright © 2021. Published by Elsevier Ltd.)