ABSTRACT
BACKGROUND: Breast neoplasms are the second most common type of cancer worldwide, and radiation therapy is a key component of their treatment. Acute skin reactions are one of the most common side effects of radiation therapy, and prevention of this adverse event has been investigated in several studies. However, a clinically applicable, preventative treatment remains unavailable. It has been demonstrated that application of a low-power laser can promote tissue repair. Therefore, the aim of this trial is to evaluate the effectiveness of an indium gallium aluminum phosphorus (InGaAIP) laser operated at 660 nm in preventing radiodermatitis in women undergoing adjuvant radiotherapy for breast cancer. METHODS/DESIGN: This is a two-arm, randomized controlled trial. A total of 52 patients undergoing radiotherapy for breast cancer (stages I to III) will be enrolled. Patients will be randomly assigned to an intervention group to receive laser therapy (n = 26) or a control group to receive a placebo (n = 26). The laser or placebo will be applied five days a week, immediately before each radiotherapy session. Skin reactions will then be graded weekly by a nurse, a radiotherapist, and an oncologist (all of whom will be blinded) using the Common Toxicity Criteria (CTC) developed by the National Cancer Institute and the Acute Radiation Morbidity Scoring Criteria developed by the Radiation Therapy Oncology Group. Patients will also answer a modified visual analogue scale for pain (a self-evaluation questionnaire). Primary and secondary outcomes will be the prevention of radiodermatitis and pain secondary to radiodermatitis, respectively. DISCUSSION: The ideal tool for preventing radiodermatitis is an agent that mediates DNA repair or promotes cell proliferation. Application of a low-power laser has been shown to promote tissue repair by reducing inflammation and inducing collagen synthesis. Moreover, this treatment approach has not been associated with adverse events and is cost-effective. Thus, the results of this ongoing trial may establish whether use of a low-power laser represents an ideal treatment option for the prevention of radiodermatitis. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02003599. Registered on 2 December 2013.
