Effect of an herbal gel for the prevention of radiation dermatitis-related symptoms: an open-label randomized clinical trial.

Abstract

Purpose of the study: Radiation-induced dermatitis (RID) is the most frequent side effect of radiotherapy; however, no effective treatments are currently available. This study investigated the efficacy and safety of an herbal gel for preventing RID and associated symptoms in patients with cancer.

Materials and methods: Cancer patients were randomly assigned 1:1 in an open-label randomized clinical trial. Patients in the prophylactic group received preventative herbal gel treatment (one day before radiotherapy). Patients in the interventional group received herbal gel treatment (upon the development of grade 2 RID). Outcome measures were scored according to the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer. Patient-reported skin symptoms (Skindex-16), quality of life (QLQ-C30), and adverse effects (CTCAE V4.0) were investigated.

Results: Among 71 participants, the prophylactic group showed significant relief with a medium effect size for itching, hurting, and burning or stinging (p < .05, effect size >0.5) compared to the interventional group. No statistically significant difference in the incidence of RID was found (51% in the prophylactic group vs. 53% in the interventional group, p = .91). The prophylactic application of the gel did not affect patient quality of life. No adverse reactions associated with the gel were observed.

Conclusions: Preventative herbal gel treatment can alleviate the radiation dermatitis-related symptoms with good safety, which indicates that gel could be an option for integration in patient care to improve RT in patients with breast, lung, and head and neck cancers.