Alpha lipoic acid for prevention of radiation-induced dermatitis in breast cancer patients: A randomized-controlled trial.

BACKGROUND: Radiation-induced dermatitis (RID) is an important side effect that occurs in 95% of patients receiving radiation therapy. The purpose of this study was to evaluate the efficacy and safety of alpha lipoic acid (ALA) in preventing RID in breast cancer patients. METHODS: In this randomized-controlled, single-blinded trial, 40 patients with breast cancer who were scheduled for radiotherapy were randomly allocated to ALA group (n = 20) who received 300 mg ALA three times daily starting at the first day of radiotherapy for 3 weeks or control group (n = 20) who did not receive any prophylaxis for RID. Primary outcomes were the incidence and severity of RID using Radiation Therapy Oncology Group (RTOG) grading criteria. Secondary outcomes were maximum grade of RID and changes in serum concentrations of interleukin-6 (IL-6). RESULTS: In ALA group, 90% and 60% of patients remained asymptomatic at the end of the second and third weeks of radiotherapy compared to 50% and 20%, respectively, in the control group. Moreover, only 10% of patients in ALA group developed ≥ grade 2 RID compared to 45% in control. A significant reduction in the serum levels of IL-6 was observed in the ALA group at the end of the study compared to control (p = 0.044). ALA was safe and well-tolerated. CONCLUSION: Prophylactic administration of ALA significantly delayed the onset and reduced the severity of RID besides its anti-inflammatory effect in breast cancer patients.