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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 < 0.05). Logistic regression analysis revealed that the risk on moist desquamation was significantly increased for patients with a large (> 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. [ABSTRACT FROM AUTHOR]

• Evaluation of the efficacy of photobiomodulation (PBM) for acute radiodermatitis. • First randomised, placebo-controlled trial in head and neck cancer patients. • PBM significantly reduces the severity of acute radiodermatitis. • Evidence for implementation of PBM in clinical practise is strengthened. 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. 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. PBMT significantly reduced NCI-CTCAE grade 2–3 ARD with 49% at the end of RT. 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. [ABSTRACT FROM AUTHOR]