Photobiomodulation therapy in breast cancer-related acute radiodermatitis cases in Brazilian women: study protocol for a randomized controlled trial.

BACKGROUND: Radiodermatitis is one of the most common radiotherapy-related side effects, which can influence patients' quality of life and affect therapeutic efficacy. Photobiomodulation therapy (PBMT) appears as a low-cost technology, with significant results in the tissue repair process. METHODS: It is a triple blind randomized controlled trial. A total of 96 patients undergoing radiotherapy for breast cancer are estimated for the sample, which will be randomly assigned to a control group to receive a placebo and the institution's standard protocol (n = 48) or to an intervention group to receive PBMT, in addition to standard therapy (n = 48). The intervention consists of applying Laser Therapy EC (DMC™, São Carlos-SP, Brazil), with power of 100mW, continuous emission mode, red wavelength (660 ± 20 nm), fluence of 10.16 J/cm2, and energy of 1 J per point, three times a week since day one, right before the radiotherapy session. Blinding will be applied to patients, evaluators, and the statistician. Skin reactions will be assessed weekly using the Acute Radiation Morbidity Scoring Criteria developed by the Radiation Therapy Oncology Group and thermal images of the irradiated area that will be captured. In addition, the impact of radiodermatitis on the quality of life will be assessed through the application of the Cancer Quality of Life Questionnaire (EORTC QLQ-30) and the Breast Cancer Quality of Life Questionnaire (EORTC QLQ -BR23) at the beginning and in the end of treatment. Data will be processed and analyzed by the statistical package R using descriptive and inferential statistics. DISCUSSION: Photobiomodulation stands out for being a non-invasive and low-cost therapy that has not been associated with adverse events. It used to stimulate wound healing by promoting tissue repair, by reducing inflammation, by stimulating collagen synthesis, and relieving pain. Cientific literature have been highlighted PBMT as an effective tool in preventing or reducing the severity of radiodermatitis and its associated symptoms, which expected to be demonstrated with this ongoing study. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (ReBEC - Registro Brasileiro de Ensaios Clínicos) - Id. RBR-7gkw3d4; Universal Trial Number (UTN) - Id. U1111-1279-1686; Plataforma Brasil/Research Ethics Committee - Id. 5.788.390, registered on 24 August 2022. https://ensaiosclinicos.gov.br/rg/RBR-7gkw3d4 .