Photobiomodulation in Radiodermatitis in People With Breast Cancer

This study is a Randomized Controlled Superiority Clinical Trial involving individuals diagnosed with breast cancer and indicated for adjuvant radiotherapy at Hospital do Câncer III of the National Cancer Institute (HCIII/INCA) in Rio de Janeiro. All individuals attending HCIII/INCA for their first consultation for adjuvant radiotherapy for breast cancer will be recruited to assess eligibility criteria for the study. Those deemed eligible will receive detailed explanations regarding the study objectives, treatment groups, adverse effects, and the voluntary nature of participation through the Informed Consent Form (ICF). Upon agreeing and signing the ICF, they will undergo an initial assessment and be randomized into one of the following groups: Active Photobiomodulation Group (intervention) or Placebo Photobiomodulation Group (control). Randomization will follow a 1:1 allocation ratio between the two groups and will be conducted using sealed, opaque envelopes in blocks of ten patients, each containing an allocation code (five codes for Active Photobiomodulation Group and five codes for Placebo Photobiomodulation Group). This method was chosen to prevent biases related to therapist or participant preferences regarding the intervention. The participants will be informed about their assigned group and the follow-up procedures throughout radiotherapy and up to three months after treatment. All assessments, interventions, and data collection will be performed by trained and qualified professionals. At the beginning of radiotherapy, all participants will receive guidance on skin care, specific home exercises for the upper limbs, and maintaining their usual physical activities, following the institutional standard of care. Sociodemographic characteristics (age, race/skin color, education level, marital status, and per capita income) and clinical data (comorbidities, physical activity, tobacco and alcohol consumption, body mass index, physiotherapy follow-up, clinical staging, cancer treatment history, post-operative scar complications, and oncologic treatment-related complications) will be collected from physical and electronic medical records. For data analysis, descriptive and comparative analyses will be performed between the intervention groups concerning selected variables and primary outcomes. Measures of central tendency and dispersion will be determined for continuous variables, and frequency distribution will be used for categorical variables. Outcome evaluations (primary and secondary) will follow an intention-to-treat analysis. The Kolmogorov-Smirnov test will be used to assess data normality. Chi-square tests will analyze categorical outcomes and will be presented in absolute and relative numbers. Student's t-tests will analyze parametric continuous outcomes and will be presented as mean and standard deviation, while the Mann-Whitney test will be used for non-parametric data, presented as median and minimum-maximum values. A significance level of p<0.05 and a 95% confidence interval will be considered for all analyses, which will be performed using SPSS (Statistical Package for the Social Sciences) version 24. This research will not impose any financial burden on participants, as assessments will be conducted during routine consultations or treatment sessions, and additional data will be collected from electronic and/or physical medical records. The intervention materials (Antares photobiomodulation device by IBRAMED®, two protective glasses for the operator and patient, power cable, fuse, and operation manual) will be provided to the Clinical Epidemiology Applied to Oncology research group (on loan from IBRAMED® during the study period). Other office supply costs will be covered by the researchers responsible for the study.