Bao Yuan Gao vs. Calendula cream for radiotherapy-induced skin toxicity in head and neck cancer: A randomized controlled trial.

Abstract

Radiation Dermatitis (RD) is a frequent side effect in head and neck cancer (HNC) patients undergoing radiotherapy, negatively affecting their quality of life. Topical treatments are used for RD management, but many lack robust evidence of efficacy. This randomized controlled trial compared the effectiveness of Bao Yuan Gao, a traditional Chinese herbal ointment, with Calendula cream, a cortisone-free topical agent, in preventing severe acute RD in HNC patients. Fifty-five patients receiving radiotherapy (60-70 Gy) with or without concurrent chemotherapy were randomized to apply either Bao Yuan Gao or Calendula cream three times daily throughout their treatment and two weeks post-treatment. RD severity was assessed weekly using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, and skin condition changes were monitored bi-weekly. Of the 55 enrolled patients, 50 completed the study. While the incidence of grade ≥ 2 dermatitis did not differ significantly between groups, Bao Yuan Gao significantly reduced erythema and improved skin moisture at week 3 (p = 0.02). Favorable trends were also observed in sensitivity, melanin deposition, pain, and reduced nutritional support needs. Bao Yuan Gao yielded measurable skin-protective effects, suggesting potential benefits beyond Calendula. These findings, aligned with its anti-inflammatory herbal properties, support further investigation in larger, dose-controlled trials.