Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: a randomized placebo controlled trial.

OBJECTIVE Acute radiation erythema and other skin reactions are common adverse effects experienced by breast carcinoma patients undergoing radiotherapy treatment. Boswellic acids are pentacyclic triterpenes extracted from the resins of the tropical tree Boswellia serrata with strong anti-inflammatory properties. This study was designed to evaluate the safety and the efficacy of the application of a base cream containing boswellic acids in a proprietary formulation (Bosexil(R)) for the prevention and relief of radiation-induced adverse effects in breast cancer patients. PATIENTS AND METHODS The acute skin reactions were clinically evaluated by visual intensity and computer-assisted skin color analysis, and toxicity was assessed by the Radiation Therapy Oncology Group (RTOG) rating scale. RESULTS These findings indicate that the use of a boswellia-based cream is effective in reducing the use of topical corticosteroids and is able to reduce the grade of erythema and the skin superficial symptoms, being well tolerated by the patients. CONCLUSIONS Further studies comparing boswellia cream with other topical agents will be appropriate to confirm the effectiveness of this treatment for breast cancer patients under radiation therapy.