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: