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Objectives: The evidence demonstrating the efcacy of photobiomodulation (PBM) therapy for preventing and managing acute radiation dermatitis (ARD) is growing steadily. The question that arises from many clinicians is, if PBM is safe for oncologic patients. This study aimed to evaluate the diseasefree survival (DFS), cancerfree survival (CFS), and overall survival (OS) of breast cancer patients treated with PBM for ARD. Methods: Clinical data of 120 breast cancer patients treated with prophylactic PBM (n = 60, 2x/week, 808−905 nm, 4 J/cm 2) or placebo (n = 60) during conventional fractionation (CF) radiotherapy (RT) between April 2015 and June 2017 were retrospectively analyzed (TRANSDERMIS trial). During followup (April 2015 to May 2022), patients underwent a complete clinical evaluation every 6 months and blood analysis and mammography yearly in the rst 5 years after the end of RT. The DFS, CFS, and OS were estimated. Results: At a median followup time of 66 months (range 4−81), there was no signicant difference in DFS (73.7% vs. 98.3%, resp., p = 0.54), CFS (68.4% vs. 77.8%, resp., p = 0.79), and OS (87.9% vs. 98.3%, resp., p = 0.30) between the placebo and PBM group. Conclusions: This paper is the rst to describe the results of a longterm followup in earlystage breast cancer patients who underwent PBM for ARD. Results suggest that using PBM in breast cancer patients undergoing CF RT does not inuence the locoregional recurrence, the development of new primary tumors, or OS. We would like to thank all patients, doctors, and nurses for their participation in TRANSDERMIS trial. In addition, we want to thank Jessa Hospital and Hasselt University for providing the needed infrastructure and software packages. This study is part of the Limburg Clinical Research Center (LCRC)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 study is supported by Kom op Tegen Kanker (Stand up to Cancer), the Flemish cancer society, LimburgsKankerfonds, and ASA Srl.

Acute radiation dermatitis (ARD) is a frequent adverse effect in patients with cancer undergoing radiotherapy (RT). The aim of this case series is to evaluate the effect of a novel skin barrier protectant in patients with ARD.The skin barrier protectant was used in four patients with different cancer types undergoing RT at two clinical sites. All patients received the standard institutional skincare alongside the novel skin barrier protectant. The skin reactions were evaluated by an RT nurse using the modified version of the Radiation Therapy Oncology Group criteria.At the final RT session, three of four patients developed erythema with or without dry desquamation. One patient presented only a minor patchy moist wound. Overall, the pain and pruritus due to ARD was low or nonexistent. No adverse events related to the skin barrier protectant were reported.This case series demonstrates the beneficial effects and safety of the novel skin barrier protectant in the management of ARD in patients with cancer of different etiologies. These results lay the foundation for future studies with larger, more homogeneous patient populations; a well-defined application scheme; and a stricter study design.

Purpose: Evaluate the efficacy of a novel skincare product for the management of chemotherapy-related dermatological toxicities. Methods: A monocentric, prospective, interventional, open-label, pretest-posttest, single-group study with cancer patients receiving chemotherapy (n = 100) was set up. All enrolled patients applied the emollient daily to their face and body for three weeks. The severity of the skin reactions was evaluated by a researcher using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at baseline and end of the trial. Patient-reported outcomes (PROs) included the frequency and severity of skin symptoms (Numerical rating scale, NRS), quality of life (QoL; Skindex-16 and Dermatology Life Quality Index), Patient Benefit Index (PBI), and treatment satisfaction. PROs were collected at baseline, weekly, and at the end of the trial. Results: According to the CTCAE and NRS, the novel emollient significantly improved the severity and frequency of xerosis and pruritus (Ps

Objectives To evaluate the efficacy of photobiomodulation therapy in breast cancer patients post-lumpectomy undergoing hypofractionated whole-breast irradiation (HF-WBI) for the prevention and management of acute radiodermatitis (ARD). Materials and methods A randomized, multicentric clinical trial (LABRA trial, NCT03924011) was set up at the Limburg Oncology Center, including the Jessa Hospital (Hasselt, BE) and Ziekenhuis Oost-Limburg (Genk, BE). A total of 71 breast cancer patients planned to undergo HF-WBI were randomized to one of the two study arms: the control group (n = 32) or the PBM group (n = 39). The PBM group received the standard institutional skincare combined with PBM (2×/week) during the complete radiotherapy (RT) course. Patients in the control group received the standard skincare combined with placebo treatment (2x/week). Patients' skin reactions were evaluated weekly during the RT treatment by using the modified version of the Radiation Therapy Oncology Group (RTOG) criteria. Results At week 3 of RT, one patient presented a grade 2 and one patient a grade 3 skin reaction in the control group, while in the PBM group, all patients still presented grade 1 ARD. At the final RT session 28% of the patients presenting grade 2-3 ARD, while in the PBM group 10% presented grade 2 and no grade 3 ARD. PBM reduced the incidence of severe ARD by 18%. However, the difference was not significant (p = 0.053). Conclusion Based on the LABRA trial results, PBM seems not able to reduce the incidence of severe ARD in breast cancer patients undergoing HF-WBI. Research in a larger patient population is recommended.

Background and purpose The purpose of this study was to investigate the effectiveness of photobiomodulation therapy (PBMT) for the prevention of acute radiation dermatitis (ARD) in head and neck cancer (HNC) patients. Materials and methods A randomised, placebo-controlled trial (RCT) with 46 HNC patients who underwent radiotherapy (RT) with or without concomitant chemotherapy was set up (DERMISHEAD trial). Patients were randomised to receive PBM or placebo treatments from the first day of RT (2×/week) alongside the institutional skincare. The severity of skin reactions was assessed by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE v4.03) and the Radiotherapy-Induced Skin Reaction Assessment Scale (RISRAS). Quality of life (QoL) was evaluated using the Skindex-16 questionnaire. Results PBMT significantly reduced NCI-CTCAE grade 2–3 ARD with 49% at the end of RT. Conclusion The results of the first RCT in HNC patients showed that PBMT is an effective method to prevent the development of severe ARD. These results support the implementation of PBM in the clinical oncology – radiotherapy practice. This research is part of the Limburg Clinical Research Center (LCRC) 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 project is funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish Cancer Society, Limburgs Kankerfonds, and ASA Srl.

Objective To evaluate the use of a novel skin barrier protectant in a patient treated with radiotherapy for vulvar cancer. Methods This case report was conducted in a radiotherapy department with two women undergoing radiotherapy for vulvar carcinoma. A novel skin barrier protectant was evaluated in one patient; the other underwent the institutional standard skin care protocol. Skin reactions and pain were evaluated using the Radiotherapy Oncology Group Criteria. Main results The patient who was treated with the skin protectant showed accelerated healing toward the end of radiotherapy, and this was accompanied with a decrease in pain (maximum pain score 6/10). In comparison, the patient treated with the standard skin care protocol had an extended healing process, experienced a higher pain level (maximum pain score 9/10), and required more nursing care. Conclusions This case report is the first to suggest that this novel skin barrier protectant could effectively manage acute radiodermatitis in patients with cancer. This case report hopes to lay the foundation for future randomized controlled trials with a larger and broader patient population.

The objective of this retrospective analysis was to determine the incidence and extent of vaginal mucositis (VM) in women with gynaecological cancer undergoing external (chemo)radiation therapy (CRT). A retrospective analysis was set up to collect data on the incidence and severity of VM in women treated with external pelvic RT for gynaecological cancer at the Jessa Hospital, Hasselt and ZOL, Genk, BE between January 2017 and June 2018. At the start and end of their external (C)RT, they rated the frequency and intensity of five common symptoms of VM. Thirty-three patients treated with RT for gynaecological cancer met the inclusion criteria. A non-negligible proportion of patients already experienced at least one VM symptom to any degree before the start of RT, a proportion that further increased towards the end of the RT (73%). At the end of RT, on average, about 25% of these patients reported moderate-to-severe symptoms (against about 7% before the (C)RT). These results suggest that VM is a rather frequent side effect in gynaecological cancer patients that aggravates during treatment up to a moderate severity level. Although the small sample size, these data highlight the need for attention to VM.Impact Statement

Humanity has overcome many obstacles that were known to be insurmountable through the desire to learn and progress continuously, particularly in the field of medicine. The fight against ailments is infinite as we evolve through the different facets of “ultra”-modernization with improved cancer diagnosis, management, and survivorship. From cancer diagnosis and through survivorship, disease and treatment-related complications arise and must be dealt with utmost care. Often these complications may jeopardize the cancer treatment itself. Avoiding medications to control these complications to the already long list of the cancer regimen drugs must be the aim of any supportive care clinician. Surgery-induced short- and long-term—often irreversible—complications, radiotherapy (RT), chemotherapy (CT), concomitant chemoradiotherapy (CRT), targeted agents, or immunotherapy, are major clinical challenges for a cancer survivor. There may be interrelated and multiple concurrent problems due to the similarities associated with pathophysiology from different complications. Anecdotal evidence suggests associated inflammation from acute complications may foster as a precursor of chronic complications. Obviously, early diagnosis and interventions such as RT and CRT may reduce acute complications and often reduce the intensity of chronic complications.

Purpose of review The number of clinical trials on the use of photobiomodulation therapy (PBMT) for the management of cancer therapy-related complications is growing steadily. One of the side-effects that is under investigation is acute radiodermatitis (ARD), an inflammatory skin reaction caused by radiotherapy. In this review, an overview is given on the state of art of the application of PBMT for the prevention and management of ARD. Recent findings Up to now about seven clinical trials have been performed, investigating the use of PBMT in the prevention and/or management of ARD. Results demonstrate that PBMT can effectively reduce the incidence of severe ARD, decrease the accompanying pain, and improve the patients' quality of life. Moreover, the technique seems to be well tolerated in oncologic patients. Summary On the basis of the available evidence, there could be a strong recommendation to use PBMT in the prevention and management of ARD in cancer patients.

Objective: We evaluated the role of photobiomodulation (PBM) in radiation fibrosis syndrome (RFS). Background: Radiation therapy (RT) is an important treatment utilized in over half of newly diagnosed cancers. Despite its benefits, patients treated with RT may experience acute and chronic significant side effects depending on both treatment- and patient-related factors. RFS is an important long-term side effect of RT, which can adversely impact patient's quality of life and organ function. With improved oncologic outcomes and survival for cancer patients after radiation, there is an unmet need to address long-term side effects of RT, particularly RFS. Results: Photobiomodulation (PBM) using low energy, nonionizing light primarily in the visible (especially red) or near-infrared spectrum has been demonstrated to decrease acute side effects of radiation in rigorously conducted phase III randomized studies; however, its potential benefit in ameliorating chronic radiation side effects, particularly RFS remains to be investigated. Conclusions: This review summarizes the in vitro data, preclinical animal studies and clinical reports, which showcase the potential benefits of PBM treatments in preventing and reversing RFS.

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of chemotherapy (CT), affecting 68% of patients. Current treatment strategies are based on pharmacological symptom management, but have limited results. Photobiomodulation therapy (PBMT) is a new and emerging therapeutic tool in the supportive care of cancer patients. In this overview, we explore the usability of PBMT for management of CIPN. Objective: To provide a comprehensive overview of management of CIPN with PBMT. Methods: Specific terms, including "Photobiomodulation Therapy," "Drug Therapy," and "Peripheral Nervous System Diseases," were identified for the literature research in PubMed. Results: Three articles were considered eligible for this review. Primary outcome measures were highly variable across the included studies. Conclusions: PBMT might be an effective treatment strategy to manage CIPN, with very encouraging reports from renowned teams, but evidence is limited. More methodologically uniform research (mainly regarding the parameters of PBMT) is needed to support the use of PBMT for this indication.

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.

Objective Acute radiodermatitis (RD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the prevention of acute RD in breast cancer (BC) patients undergoing RT. Methods This study was a randomized, placebo-controlled trial including 120 BC patients that underwent an identical RT regimen post-lumpectomy. Patients were randomly assigned to the laser therapy (LT) or placebo group, with 60 patients in each group. Laser or placebo treatments were applied 2 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 ). Skin reactions were scored based on the criteria of the Radiation Therapy Oncology Group (RTOG) and the Radiation-Induced Skin Reaction Assessment Scale (RISRAS). The patients completed the Skindex-16 questionnaire to evaluate their quality of life. All the measurements were collected at the first day, at a RT dose of 40 Gray (Gy), and at the end of RT (total dose 66 Gy). Results At a RT dose of 40 Gy, there was no significant difference between the groups in the distribution of RTOG grades. However, at the end of RT the severity of the skin reactions significantly differed between the two groups (P = 0.004), with a larger percentage of patients experiencing RTOG grade 2 or higher (e.g., moist desquamation) in the placebo group (30% vs. 6.7%, for the placebo and laser group, resp.). The objective RISRAS score confirmed these results. In addition, the Skindex-16 and RISRAS subjective score demonstrated that the patients' quality of life was significantly better in the LT than in the control group. Conclusions The results of this trial show that PBMT is an effective tool to prevent the development of grade 2 acute RD or higher in BC patients. In addition, it also reduces the patients' symptoms related to RD. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc.

Radiodermatitis (RD) is a cutaneous reaction that occurs as a side-effect of radiotherapy during cancer treatment or sometimes after interventional radiology. There are two forms of RD depending on the time the skin reaction occurs. Acute skin reactions develop a few hours to weeks after the first e

Radiation dermatitis (RD), an inflammatory skin disease that can be an unwanted side effect of medical radiation therapy (RT), most commonly occurs in patients undergoing cancer of the ENT, anal, and vulvar regions. The side effects on the skin and mucous membranes occur within a few weeks after the initiation of RT; however, late side effects can develop months to years after the RT. Therapeutically, various treatment approaches are considered such as pentoxifylline, hyperbaric oxygen therapy, laser therapy, and PBMT. In order to limit the reduced quality of life of patients with RT-induced fibrosis, supportive care consisting of pain therapy, psychological support, and wound care is necessary.

Breast cancer is the most common cancer in women worldwide, with an incidence of 1.7 million in 2012. Breast cancer and its treatments can bring along serious side effects such as fatigue, skin toxicity, lymphedema, pain, nausea, etc. These can substantially affect the patients' quality of life. Therefore, supportive care for breast cancer patients is an essential mainstay in the treatment. Low-level light therapy (LLLT) also named photobiomodulation therapy (PBMT) has proven its efficiency in general medicine for already more than 40 years. It is a noninvasive treatment option used to stimulate wound healing and reduce inflammation, edema, and pain. LLLT is used in different medical settings ranging from dermatology, physiotherapy, and neurology to dentistry. Since the last twenty years, LLLT is becoming a new treatment modality in supportive care for breast cancer. For this review, all existing literature concerning the use of LLLT for breast cancer was used to provide evidence in the following domains: oral mucositis (OM), radiodermatitis (RD), lymphedema, chemotherapy-induced peripheral neuropathy (CIPN), and osteonecrosis of the jaw (ONJ). The findings of this review suggest that LLLT is a promising option for the management of breast cancer treatment-related side effects. However, it still remains important to define appropriate treatment and irradiation parameters for each condition in order to ensure the effectiveness of LLLT.

The aim of this Letter to the Editor was to report some methodological shortcomings in the recently published article “Application of red light phototherapy in the treatment of radioactive dermatitis in patients with head and neck cancer” by Zhang et al. There are some issues regarding the incomplete photobiomodulation (PBM) parameters, the chosen outcome measures, and some missing reference articles. In conclusion, the results of this study should be interpreted with caution and further research is necessary. JR and JM received funding from the following organisations: Limburg Clinical Research Program supported by the foundation Limburg Sterk Merk, province of Limburg, Flemish government, Hasselt University, Ziekenhuis Oost-Limburg, and Jessa Hospital. ASA srl. Limburgs Kankerfonds Kom op Tegen Kanker

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.

Acute radiodermatitis (RD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the prevention of acute RD in breast cancer (BC) patients undergoing RT.This study was a randomized, placebo-controlled trial including 120 BC patients that underwent an identical RT regimen post-lumpectomy. Patients were randomly assigned to the laser therapy (LT) or placebo group, with 60 patients in each group. Laser or placebo treatments were applied 2 days a week, immediately after the RT session, starting at the first day of RT. PBMT was delivered using a class IV MLSAt a RT dose of 40 Gy, there was no significant difference between the groups in the distribution of RTOG grades. However, at the end of RT the severity of the skin reactions significantly differed between the two groups (P = 0.004), with a larger percentage of patients experiencing RTOG grade 2 or higher (e.g., moist desquamation) in the placebo group (30% vs. 6.7%, for the placebo and laser group, resp.). The objective RISRAS score confirmed these results. In addition, the Skindex-16 and RISRAS subjective score demonstrated that the patients' quality of life was significantly better in the LT than in the control group.The results of this trial show that PBMT is an effective tool to prevent the development of grade 2 acute RD or higher in BC patients. In addition, it also reduces the patients' symptoms related to RD. Lasers Surg. Med. © 2018 Wiley Periodicals, Inc.

The aim of this study was to assess the effectiveness and acceptability of photobiomodulation using MLS® laser therapy (LT) in the management of acute radiation dermatitis (RD). We compared two successive groups of breast cancer patients undergoing identical radiotherapy regimens post-lumpectomy. Both groups received our standard skin care but the second group received six additional LT sessions (beam area 19.635 cm2, 0.168 W/cm2, 4 J/cm2), starting at fraction 20 of radiotherapy (control and LT group, N = 41 and 38, respectively). The clinical outcomes were the severity of RD (using the Radiation Therapy Oncology Group [RTOG] criteria and the Radiotherapy-Induced Skin Reaction Assessment Scale [RISRAS]) and dermatology-specific quality of life (Skindex-16) before the start of LT and at the end of radiotherapy. Secondary outcomes were patients’ ratings of skin care or LT (pleasantness, soothing effect, and global satisfaction). Skin toxicity was equivalent between the groups before the start of LT but significantly differed at the end of radiotherapy, with an aggravation in the control but not in the LT group (e.g., 29 versus 3 % of RTOG grade 2 RD, respectively, P

Aim: The aim of this study was to assess the efficacy of low level laser therapy (LLLT) in managing radiation dermatitis (RD) in breast cancer patients. Methods: This prospective study compared two successive groups of breast cancer patients undergoing identical radiotherapy regime post-lumpectomy. The first group received our standard skin care protocol (CTRL group, N=27) and the second one, this standard protocol plus LLLT (6 sessions), starting at fraction 20 of radiotherapy (LLLT group, N=27). Other patients' and treatment characteristics were equivalent between groups. LLLT was provided two times a week, using a laser characterized by two assembled laser diodes with synchronized emissions at 808 nm and 905 nm, respectively. The energy density was fixed at 4 J/ cm2. Skin toxicity was assessed by trained nurses before the start of LLLT and at the end of radiotherapy according to the Radiation Therapy Oncology Group (RTOG) criteria. Results: Skin toxicity for the CTRL and LLLT groups before LLLT and at the end of radiotherapy are presented in Table 1. Before LLLT (i.e., at fraction 20), skin toxicity was equivalent in the two groups (p = .526), with most patients presenting RTOG grade 1. At the end of radiotherapy (i.e. after 6 LLLT), however, the severity of RD significantly differed between the two groups (p = .004): There was a significant intensification of RD in the CTRL but not in the LLLT group. Table 1. Skin toxicity for the control (CTRL) group and the group receiving low level laser therapy (LLLT) before the start of LLLT (at fraction 20) and at the end of radiotherapy (RT, after 6 LLLT-sessions). CTRL group LLLT group Before LLLT End RT p* Before LLLT End RT p* RTOG grade N (%) N (%) .012 N (%) N (%) .491 0 3 (11.1) 0 2 (7.4) 0 1 23 (85.2) 19 (70.4) 25 (92.6) 27 (100) 2 1 (3.7) 8 (29.6) 0 0 * Chi-square test or Fisher's exact test (two-tailed). Conclusions: Typically, RD evolves into more severe forms as radiation therapy progresses, as observed in our control patients. LLLT seemed to have stopped this progression of RD, as skin toxicity remained stable throughout radiotherapy in patients receiving LLLT. These findings indicate a beneficial effect of LLLT on RD in breast cancer patients. This is the first prospective study to evaluate the potential of LLLT for RD. These promising results warrant further research on the efficacy of LLLT in preventing and managing acute RD. Disclosure: All authors have declared no conflicts of interest.

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