Study of Alpha Lipoic Acid to Prevent Radiation-Induced Skin Problems in Women with Early-Stage Breast Cancer Receiving Radiation Therapy

What this Trial Is About

Researchers are studying the effect of Alpha Lipoic Acid on radiation-induced dermatitis in women with early-stage breast cancer undergoing radiation therapy. Radiation therapy uses high-energy waves to destroy tumor cells but can also harm nearby normal skin cells, causing radiation-induced dermatitis RID in about 95% of patients. This condition leads to skin redness, peeling, and discomfort, which can affect daily activities and interrupt cancer treatment. The study aims to understand whether Alpha Lipoic Acid, known for its anti-inflammatory and antioxidant properties, can help prevent or reduce RID during radiation therapy. In this randomized trial, participants are assigned to one of two groups. One group will receive Alpha Lipoic Acid 300 mg three times daily under the trade name THIOTACID, starting from the first day of radiation therapy until the study ends. The other group will receive no preventive treatment as there is currently no standard care for RID prevention. The radiation therapy involves a total dose of 40 Gy over 15 sessions. The study duration covers the 3 weeks of radiation therapy and the observation period. Participants will be monitored weekly after every fifth radiotherapy session for the development and severity of radiation-induced dermatitis. Blood samples will be collected at the beginning and end of the study to measure levels of the inflammatory biomarker interleukin-6. Researchers will also track any treatment-related side effects during the treatment period. The study includes women aged 18 to 75 with confirmed invasive breast cancer receiving adjuvant radiotherapy and excludes those with prior radiotherapy or skin conditions that might interfere. Total participation lasts about 3 weeks during radiation therapy.

Evaluation of the Effect of Alpha Lipoic Acid on Radiation Induced Dermatitis in Breast Cancer Patients