A blinded-endpoint, randomized controlled trial of Sanyrene with natural active ingredient for prophylaxis of radiation dermatitis in patients receiving radiotherapy

Abstract

Abstract Background Randomized controlled study was conducted to evaluate the efficacy of Sanyrene® vs. control intervention (DaBao®, a complex of hyaluronic acid and Vitamin E) for acute radiation dermatitis in patients receiving radiotherapy. Methods Patients with breast cancer or head and neck cancer undergoing radiotherapy (≥ 50 Gy) were eligible. Participants were randomly assigned to either Sanyrene arm or control intervention arm in a ratio of 1:1. The primary endpoint was incidence rate of ≥ grade 2 radiation induced dermatitis. (Trial Registration: ChiCTR2100050910, registration date: 9/7/2021) Results A total of 102 eligible patients were randomly assigned into the study. The rate of ≥ grade 2 radiation dermatitis was 22% in Sanyrene group, as compared with 67.3% in the control intervention group (P<0.001). The incidence of grade 3 radiation dermatitis was 20.4% and 8.0% in control intervention group and Sanyrene group, respectively (P = 0.076). Patients in Sanyrene group had a longer median time to reach ≥ grade 2 radiation dermatitis compared to these in control intervention group, with hazard ratio of 0.231 (95%CI:0.116–0.458, p < 0.001). Mean score of SD-16 were much higher in control intervention group than Sanyrene group at end of radiotherapy (25 vs.8.3), 2 weeks after radiotherapy (22.9 vs. 0.5) and 4 weeks after radiotherapy (4.2 vs.0), with significantly statistical difference between two groups. Conclusions This trial suggests that Sanyrene is effective on preventing serious radiation dermatitis and improving skin related quality of life in patients with breast cancer or head and neck cancer receiving radiotherapy.