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Objective: A narrative review of the available scientific evidence to identify the current proposals relating the use of photobiomodulation (PBM) to treat acute radiodermatitis (ARD), to guide future research. Background data: A devastating side effect of radiotherapy (RT) is ARD, defined as an inflammatory skin reaction induced by RT. Currently, there is still no standard of care for ARD. PBM is a non-invasive light therapy that is a growing modality in the field of supportive cancer care. There is a need for identifying the therapeutic irradiation windows in this field, based on the available literature. Methods: An electronic search of original articles in the PubMed database was performed with the following keywords: “photobiomodulation therapy,” “low-level light therapy,” “low-level laser therapy,” “acute radiodermatitis,” and “radiotherapy” until December 2019. Randomized controlled trials, prospective non-randomized, case report, cohort, cross-over, and retrospective studies were selected for this review. Results: Nine clinical trials that investigated the use of photobiomodulation therapy (PBMT) in ARD were available for evaluation. Results demonstrate that PBMT could significantly reduce the severity of ARD and the accompanying discomfort and pain in patients with cancer. Conclusions: Based on the available evidence of the narrative review, PBM might be an effective therapy for the prevention and management of ARD in patients with cancer. More research is needed to confirm this finding. Foundation Limburg Sterk Merk Province of Limburg Flemish government Hasselt University Ziekenhuis Oost-Limburg Jessa Hospital Kom op Tegen Kanker Limburgse Kankerfonds ASA Srl

Background The aim is to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the prevention of acute radiodermatitis (RD) in breast cancer patients undergoing radiotherapy (RT). Study Design/Materials and Method This randomized, placebo-controlled trial enrolled 66 breast cancer patients that underwent an identical RT regime post-lumpectomy. Patients were randomly assigned to the laser (n=34) or placebo group (n=32). There were no significant differences between the two groups with respect to patient- and treatment-related characteristics. Laser or placebo was applied two days a week, immediately after the RT session, starting at the first day of RT. PBMT was delivered using a class IV MLS® M6 laser that combines two synchronized laser diodes in the infrared range (808-905 nm) with a fixed energy density (4 J/cm2). Clinical scoring of RD (Radiation Therapy Oncology Group (RTOG) grading scale) and biophysical measurements (skin hydration, transepidermal water loss (TEWL), and degree of erythema) were determined at the first day, at fraction 20 and at the end of RT. In the results section, only preliminary results of the RTOG scores are shown. Results At fraction 20 of RT, there was no significant difference between the groups in the distribution of RTOG grades (p= .524), with most of the patients presenting RTOG grade 1. Towards the end of RT, the skin reactions worsened in the placebo group (p= 0.016), while they remained stable in the laser group (p= .207). There was a significant difference in the severity of RD between the two groups (p= .021) with a larger percentage of patients experiencing RTOG grade 2 or higher (e.g. moist desquamation) in the placebo group (28.1% vs. 5.9%, for the placebo and laser group, resp.) at the last day of RT. Conclusion The preliminary results of this first randomized, placebo-controlled trial show that PBMT can prevent aggravation of acute RD in breast cancer patients. LCRP; Limburgs Kankerfonds; ASA srl

Photobiomodulation therapy is based on the application of visible and/or (near-)infrared light on the target tissue. We performed a review of 34 articles on the use of photobiomodulation therapy in the management of cancer related lymphoedema, oral mucositis, radiodermatitis, chemotherapy-induced peripheral neuropathy, osteonecrosis of the jaw, and xerostomia/hyposalivation. The findings suggest that photobiomodulation therapy is a promising option for the management of these cancer therapy-related side effects. This study is part of the Limburg Clinical Research Program (LCRP) UHasselt-ZOL-Jessa, supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg and Jessa Hospital. Additionally, this research is supported by the foundations Limburgs Kankerfonds, Kom op Tegen Kanker and ASA srl.

Purpose The purpose of this study was to evaluate objectively the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) by using biophysical skin measurements. Methods A randomized, placebo-controlled trial with 120 breast cancer patients who underwent an identical radiotherapy (RT) regimen post-lumpectomy was performed (TRANSDERMIS trial). Patients were randomized to receive PBM (808 nm CW/905 nm pulsed, 168 mW/cm2, spot size 19.6 cm2, fluence 4 J/cm2) or placebo treatments from the first day of RT (2×/week). Biophysical skin measurements were collected to assess the skin pigmentation and barrier function. Measurements were collected at the first day of RT, a RT dose of 40 Gray (Gy), and the end of RT (66 Gy). Results The incidence of moist desquamation was significantly higher in the control than in the PBMT group at the end of RT (30 vs. 7%, respectively, odds ratio = 6, p = 0.004). The biophysical skin measures showed that the mean percentage change from the baseline transepidermal water loss (TEWL), erythema, and melanin values was significantly higher in the control than in the PBMT group at the end of RT (ps 800 cc) breast volume (odds ratio = 4, p = 0.017). Conclusions This is the first randomized controlled trial demonstrating by objective measurements that PBMT is effective in reducing the incidence of moist desquamation in breast cancer patients undergoing RT. Additionally, a large breast volume is an important risk factor for the development of moist desquamation. This research is part of the Limburg Clinical Research Program (LCRP) UHasselt-ZOL-Jessa, financially supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. Additionally, this research is supported by Kom op Tegen Kanker, Limburgs Kankerfonds, and ASA Srl.

Background: The aim of our study was to investigate the efficacy of photobiomodulation therapy (PBMT) for the prevention of radiodermatitis (RD) in breast cancer patients. Methods: This is a randomized controlled, patient-blinded study with breast cancer patients that underwent an identical radiotherapy (RT) regime post-lumpectomy. A total of 57 patients were enrolled and randomly assigned to the intervention group to receive laser therapy (LT, n = 30) or the control group to receive a sham treatment (n = 27). LT or sham was applied two days a week, immediately after the RT session, starting at the first day of RT. LT was delivered using a class IV MLS® laser that combines two synchronized laser diodes in the infrared range (808-905 nm) with a fixed energy density (4 J/cm2). There were no significant differences between the two groups with respect to patient- and treatment-related characteristics. The skin reactions were evaluated by trained, blinded nurses at fraction 20 and at the end of RT (fraction 33) according to the criteria of the Radiation Therapy Oncology Group (RTOG). Results: At fraction 20 of RT the distribution of the RTOG grades was comparable between both groups ( p= .238), with most of the patients presenting RTOG grade 1. At the end of RT, the severity of RD significantly differed between the two groups ( p= .035), with a greater proportion of patients experiencing RD grade 2 or higher in the control group (30% vs. 7%, for the control and LT group, resp.). The skin reactions of the patients in the control group aggravated ( p= .006), while they remained stable in the LT group ( p= .205).Conclusions: In the control group the skin reactions developed into more severe forms (e.g. moist desquamation) towards the end of RT, whereas in the LT group the skin reactions remained stable. Results of this study show that PBMT is able to prevent aggravation of acute skin reactions of breast cancer patients undergoing RT. Hasselt University, Limburg Sterk Merk, Province of Limburg, Jessa Hospital, Flemish Government, Limburgs Kankerfonds, ASA srl