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Objective The Japanese Psycho-Oncology Society and the Japanese Association of Supportive Care in Cancer have recently revised the clinical practice guidelines for delirium in adult cancer patients. This article reports the process of developing the revised guidelines and summarizes the recommendations made. Methods The guidelines were developed in accordance with the Medical Information Network Distribution Service creation procedures. The guideline development group, consisting of multi-disciplinary members, created three new clinical questions: non-pharmacological intervention and antipsychotics for the prevention of delirium and trazodone for the management of delirium. In addition, systematic reviews of nine existing clinical questions have been updated. Two independent reviewers reviewed the proposed articles. The certainty of evidence and the strength of the recommendations were graded using the grading system developed by the Medical Information Network Distribution Service, following the concept of The Grading of Recommendations Assessment, Development, and Evaluation system. The modified Delphi method was used to validate the recommended statements. Results This article provides a compendium of the recommendations along with their rationales, as well as a short summary. Conclusions These revised guidelines will be useful for the prevention, assessment and management of delirium in adult cancer patients in Japan.

Delirium occurs very frequently in cancer patients. Insomnia is a symptom of delirium. Lemborexant is a drug that regulates sleep-wake rhythms without causing extrapyramidal symptoms. Based on its ability to improve sleep, lemborexant is expected to have efficacy for insomnia with delirium. The purpose of this study was to determine the efficacy of lemborexant for insomnia in cancer patients with delirium. A retrospective observational study was conducted between July 2020 and February 2021. Fourteen patients (six females; mean age,69 years) were included. Lemborexant was effective in 11 of 14 (78.6%) patients. Of 14 patients, 10 had hyperactive delirium. Lemborexant might have similar efficacy for insomnia with and without delirium when compared with previous studies. The efficacy rate of lemborexant was 70% for patients with insomnia and hyperactive delirium. This study might lead to dose reductions of antipsychotic medications and fewer extrapyramidal symptoms in cancer patients with delirium.

Objective Preventing postoperative delirium with agitation is vital in the older population. We examined the preventive effect of yokukansan on postoperative delirium with agitation in older adult patients undergoing highly invasive cancer resection. Methods We performed a secondary per-protocol analysis of 149 patients’ data from a previous clinical trial. Patients underwent scheduled yokukansan or placebo intervention 4–8 days presurgery and delirium assessment postoperatively. Delirium with agitation in patients aged ≥75 years was assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and the Japanese version of the Delirium Rating Scale-Revised-98. We assessed odds ratios for yokukansan (TJ-54) compared with placebo for the manifestation of postoperative delirium with agitation across patients of all ages (n = 149) and those aged ≥65 years (n = 82) and ≥ 75 years (n = 21) using logistic regression. Results Delirium with agitation manifested in 3/14 and 5/7 patients in the TJ-54 and placebo groups, respectively, among those aged ≥75 years. The odds ratio for yokukansan vs. placebo was 0.11 (95% confidence interval: 0.01–0.87). An age and TJ-54 interaction effect was detected in patients with delirium with agitation. No intergroup differences were observed in patients aged ≥65 years or across all ages for delirium with agitation. Conclusions This is the first study investigating the preventive effect of yokukansan on postoperative delirium with agitation in older adults. Yokukansan may alleviate workforce burdens in older adults caused by postoperative delirium with agitation following highly invasive cancer resection.

Background The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer recently launched the clinical practice guidelines for delirium in adult cancer patients. The aim of the guidelines was to provide evidence-based recommendations for the clinical assessment and management of delirium in cancer patients. This article reports the process of developing the guideline and summarizes the recommendations made. Methods The guidelines were developed in accordance with the Medical Information Network Distribution Service creation procedures. The guideline development group, consisting of multidisciplinary members, formulated nine clinical questions. A systematic literature search was conducted to identify relevant articles published prior to through 31 May 2016. Each article was reviewed by two independent reviewers. The level of evidence and the strength of the recommendations were graded using the grading system developed by the Medical Information Network Distribution Service, following the concept of The Grading of Recommendations Assessment, Development and Evaluation system. The modified Delphi method was used to validate the recommendation statements. Results This article provides a summary of the recommendations with rationales for each, as well as a short summary. Conclusions These guidelines will support the clinical assessment and management of delirium in cancer patients. However, additional clinical studies are warranted to further improve the management of delirium., The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer launched the guidelines for delirium. This article reports the process of developing the guideline and summarizes the recommendations.

Background Optimal cancer survivorship care needs its comprehensive guidelines. We aimed to identify English and Japanese guidelines that include cancer survivorship in their title, the issues highlighted in such guidelines, and any existing oncology practice guidelines in Japan that address these issues. Methods This literature review was performed in three stages. First, guidelines published in English or Japanese that included cancer survivorship in the title were identified. Then, the issues that each cancer survivorship guideline addressed were defined. Lastly, Japanese guidelines that include survivorship issues were sought. Results Six guidelines published in English addressed 31 cancer survivorship issues. No specific cancer survivorship guideline was available in Japanese. Thirty-four Japanese guidelines mentioned cancer survivorship issues. These guidelines addressed screening/surveillance for detecting recurrence or secondary cancer but did not address coordination of care, implications for practice, or inclusion of family. At present, Japanese guidelines poorly address the issue of promotion of a healthy lifestyle in cancer survivors. Also, poorly addressed were long-term and late effects such as pain, psychological distress, fatigue, cognitive dysfunction, cardiovascular effects (including anthracycline-induced cardiac toxicity), sleep disorders, and sexual dysfunction in cancer survivors. Conclusion There is a need for guidelines on optimal coordination of care between oncologists and other health care providers to support patients along the cancer care continuum and specifically to encourage a healthy lifestyle as part of cancer survivorship. The development of a comprehensive Japanese guideline that addresses these issues would help to improve the clinical outcome for cancer survivors in Japan.

Postoperative delirium is a common and important complication in cancer patients. We need to identify patients at high risk of postoperative delirium such that it can be prevented preoperatively or in early postoperative phase. The aim of this study was to investigate whether preoperative anxiety predicted onset of postoperative delirium in cancer patients, not only in order to identify high-risk groups but also to help develop new preventive approaches. This was a prospective observational cohort study of cancer patients undergoing tumor resections. Postoperative delirium was assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Preoperative anxiety was evaluated with the Hospital Anxiety and Depression Scale-Anxiety (HADS-A), and we defined HADS-A > 7 as clinical anxiety. We conducted multivariate logistic regression to determine which factors were predictors of delirium. The final analysis included 91 patients, 29 of whom met the criteria for postoperative delirium. In multivariable logistic regression, age (5-year increments; odds ratio (OR) = 1.565, 95% confidence interval (CI) = 1.057–2.317, p = 0.025) and HADS-A > 7 (OR = 4.370, 95% CI = 1.051–18.178, p = 0.043) predicted delirium onset. These variables explained 74.2% of the variance. Preoperative anxiety strongly predicted postoperative delirium in cancer patients. Our findings suggest that preoperative anxiety may be a new target for prevention of postoperative delirium. Trial registration number This study was registered at UMIN000018980

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 124 kb)

Background Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard preventive or therapeutic methods have been established for them. Yokukansan, a Japanese herbal medicine for the treatment of insomnia and anxiety, causes relatively few adverse drug reactions and effectively improves the behavioral and psychological symptoms of dementia. Thus, it is expected to be useful for treating and/or preventing perioperative psychiatric symptoms in patients with cancer. The objective of this study is to clarify the therapeutic effect of Yokukansan for preoperative anxiety and its preventive effect on postoperative delirium in cancer patients, as well as to confirm its safety profile. Methods This study is a randomized, double-blind, placebo-controlled study in cancer patients scheduled to undergo tumor resection. Patients who provide consent are randomly allocated to receive oral administration of Yokukansan or placebo, and study drug administration is continued for 4 days or longer prior to surgery. We defined two primary endpoints, change in preoperative anxiety and incidence of postoperative delirium. Secondary endpoints are severity score of postoperative delirium, duration of postoperative delirium, amount of benzodiazepines used prior to surgery, amount of antipsychotic agents used after surgery, and number of postoperative hospitalization days. We plan to complete the analysis on March 31, 2021. The target number of registered patients is 110 per group, or 220 in total. Discussion This study is the first randomized, double-blind, placebo-controlled study intended to clarify the effects of a Japanese herbal medicine, Yokukansan, in the prevention and treatment of perioperative psychiatric symptoms in patients with cancer. The trial was initiated on August 14, 2017, with 195 subjects randomized by October 5, 2018. Trial registration UMIN Clinical Trials Registry (UMIN-CTR), UMIN000027561. Registered on 31 May 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3202-1) contains supplementary material, which is available to authorized users.

Background Yokukansan (YKS), a Japanese traditional herbal medicine for neurosis and insomnia, is speculated to be useful for perioperative psychiatric symptoms in cancer patients, but there exists little empirical evidence. This study provides preliminary data about the efficacy, feasibility, and side effects of YKS for the treatment of preoperative anxiety and postoperative delirium in cancer patients. Methods We retrospectively reviewed the medical records of colorectal cancer patients who took YKS for preoperative anxiety, evaluating the following: (1) patient characteristics, (2) feasibility of taking YKS, (3) changes in preoperative anxiety based on the Clinical Global Impression (CGI) scale and Edmonton Symptom Assessment System-revised (ESAS-r-anxiety), (4) incidence of postoperative delirium and (5) YKS-related side effects. Results We reviewed 19 medical records. There was a significant difference between ESAS-r-anxiety scores (P = 0.028) before and after taking YKS, but no difference between CGI scores (P = 0.056). The incidence of postoperative delirium was 5.2% (95% CI = 0.0-14.5). One patient could not complete the course of YKS during the perioperative administration period, but there were no side effects of Grade 2 or worse according to the Common Terminology Criteria for Adverse Events v4. Conclusions Cancer patients could safely take YKS before surgery. There was a significant improvement in preoperative anxiety after taking YKS, and the incident rate of postoperative delirium was lower than in previous studies. These results suggest that YKS may be useful for perioperative psychiatric symptoms in cancer patients. Further well-designed studies are needed to substantiate our results.

Surgery is one of the main treatments component against cancer. Although the basic principle of surgical treatment of cancer is curability, safety, and functionality, early recovery after surgery is also important. While some previous studies focus on physical recovery, there are few studies regarding the perioperative period of cancer patients and their impact on postoperative recovery. This study is aim to clarify psychosocial factors that affect postoperative recovery in cancer patients. The study design is a secondary data analysis of a prospective observational cohort study whose primary purpose was to investigate whether preoperative anxiety predicted onset of postoperative delirium in cancer patients at the National Cancer Center Hospital in Japan. The primary outcome of this study was the length of postoperative hospital stay, and the secondary outcome was postoperative complications. We conducted multivariable regression analysis to determine psychosocial predictors of primary and secondary outcomes. The final analysis included 109 patients. The mean length of postoperative hospital stay was 23.4 (SD = 12.4) days and the incidence rate of postoperative complications was 32.1%. In multivariable regression, preoperative anxiety was positively associated with the length of postoperative hospital stay, while sex (female) and alcohol dependence showed a negative association. Cognitive function was marginally associated with postoperative complications. In conclusion, Appropriate management of preoperative anxiety contributes to early discharge after surgery in cancer patients.

Importance Although several pharmacological interventions for delirium have been investigated, their overall benefit and safety remain unclear. Objective To evaluate evidence regarding pharmacological interventions for delirium treatment and prevention. Data Sources PubMed, Embase, ProQuest, ScienceDirect, Cochrane Central, Web of Science, ClinicalKey, and ClinicalTrials.gov from inception to May 17, 2018. Study Selection Randomized clinical trials (RCTs) examining pharmacological interventions for delirium treatment and prevention. Data Extraction and Synthesis To extract data according to a predetermined list of interests, the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines were applied, and all meta-analytic procedures were conducted using a random-effects model. Main Outcomes and Measures The primary outcomes were treatment response in patients with delirium and the incidence of delirium in patients at risk of delirium. Results A total of 58 RCTs were included, in which 20 RCTs with 1435 participants (mean age, 63.5 years; 65.1% male) compared the outcomes of treatment and 38 RCTs with 8168 participants (mean age, 70.2 years; 53.4% male) examined the prevention of delirium. A network meta-analysis demonstrated that haloperidol plus lorazepam provided the best response rate for delirium treatment (odds ratio [OR], 28.13; 95% CI, 2.38-333.08) compared with placebo/control. For delirium prevention, the ramelteon, olanzapine, risperidone, and dexmedetomidine hydrochloride groups had significantly lower delirium occurrence rates than placebo/control (OR, 0.07; 95% CI, 0.01-0.66 for ramelteon; OR, 0.25; 95% CI, 0.09-0.69 for olanzapine; OR, 0.27; 95% CI, 0.07-0.99 for risperidone; and OR, 0.50; 95% CI, 0.31-0.80 for dexmedetomidine hydrochloride). None of the pharmacological treatments were significantly associated with a higher risk of all-cause mortality compared with placebo/control. Conclusions and Relevance This network meta-analysis demonstrated that haloperidol plus lorazepam might be the best treatment and ramelteon the best preventive medicine for delirium. None of the pharmacological interventions for treatment or prophylaxis increased the all-cause mortality.

The aim of this study is to describe physicians' clinical practice of discussing fertility issues with cancer patients and determine the factors associated with such discussion.In this cross-sectional study, a nationwide Internet survey was conducted among physicians who provided daily medical care to cancer patients at hospitals or clinics. Participants answered a questionnaire assessing characteristics, discussion practices, attitudes, and barriers regarding fertility preservation.Among the 180 participants, 42% discussed fertility issues with patients daily, and 30% had experience in referring patients to fertility preservation specialists. A multivariate logistic regression analysis showed that those who agreed or strongly agreed with the statements "physicians are responsible for discussing fertility preservation" (OR = 2.04, 95% CI 1.14-3.63, p 0.05) and "patients who have an exceedingly aggressive disease and need immediate cancer treatment should not be told about fertility issues" (OR =1.84, 95% CI 1.09-3.10, p 0.05) were nearly twice as likely to discuss fertility issues with patients.Compared to Western countries, fertility issues are less likely to be discussed in Japan. To increase opportunities for patients to discuss fertility issues, the ASCO guidelines should be widely understood. Additionally, these results suggest that physicians who are more likely to discuss fertility issues might feel more conflicted about whether they in fact should discuss such issues with patients with poor prognosis or insufficient time for cancer treatment.

Context There is controversy around the association between depressive symptoms and age in adult cancer patients. Objectives The aim of this study was to evaluate the following hypotheses: 1) cancer patients' depressive symptoms decrease with age, and 2) in individuals aged 65 years or older, depressive symptoms increase because of the effect of somatic symptoms. Methods We retrospectively analyzed a database of 356 cancer patients who were consecutively recruited in a previous multicenter cross-sectional study. Depressive symptoms were assessed by the Patient Health Questionnaire-9 (PHQ-9), and correlations with age and other factors were assessed by hierarchical multivariate regression analysis. Age was entered as the dependent variable in the first step, patient characteristics and cancer-related variables were entered in the second step, and somatic symptoms were entered in the last step. We analyzed this model for both the total sample and the subpopulation aged 65 years or older. Results In the total sample, the PHQ-9 score was significantly associated with lower age, fatigue, and shortness of breath (adjusted R 2 14.2%). In the subpopulation aged 65 years or older, no factor was associated with the PHQ-9 score (adjusted R 2 7.3%). Conclusion The finding that depressive symptoms in cancer patients decreased with age was concordant with our first hypothesis, but the second hypothesis was not supported. Younger cancer patients were vulnerable to depressive symptoms and should be monitored carefully. Further studies using more representative samples are needed to examine in detail the association between depressive symptoms and age in older cancer patients.

Myxofibrosarcoma (MFS) has a spectrum of malignant fibroblastic lesions with variably myxoid stroma and pleomorphism. A 67-year-old man with a bulky mass on his chest wall was diagnosed with MFS. He underwent F-18 fluorodeoxyglucose (FDG) positron emission tomography/computed tomography for detection of metastasis. FDG positron emission tomography /computed tomography showed inhomogeneous high FDG uptake (max standardized uptake value, 10.1) in the bulky tumor with no evidence of metastasis, and the tumor was successfully resected. FDG uptake seemed to be reflected by the broad spectrum of pathologic heterogeneity. And MFS should be considered when making a diagnosis of inhomogeneous FDG-avid lesions in the bulky masses of soft tissue.