FR-101 Dressing May Alleviate Radiation-Irritated Skin After Radiotherapy in Breast Cancer Patients ― A Pilot Clinical Trial

Abstract

Whole breast radiotherapy after breast-conserving surgery reduces the risk of recurrence and death and is widely used as standard treatment for breast cancer. Radiation-irritated skin, defined as "post-radiotherapy pruritic dry skin easily irritated by external stimulation, such as seasonal change or topical products", affects quality of life of breast cancer survivors undergoing whole breast radiotherapy. FR-101 dressing is a novel dressing combined with biocellulose membrane and repair peptides to repair the damaged skin after radiotherapy. This study is aimed to test the safety and efficacy to alleviate radiation-irritated skin symptoms.The study was a single-arm, open label, single center pilot clinical study to evaluate the safety and clinical outcome of the FR-Mask intervention in breast cancer patients after WBRT. Patients who complete the post-operative radiotherapy and meet the inclusion and exclusion criteria had been enrolled into the study after the study team obtains their informed consent. Each subject had received 12 packages of FR-Mask (1 mask in each individual package) and be instructed to put the patch on the irritated-skin area caused by radiation for 20 minutes every 3 days. Subjects came back to clinics for evaluation every 4 weeks for 4 months, and received physical examination and investigations including questionnaires, skin observer measurement, and taking pictures. The total study duration for each subject took 4.5 months. This study had been conducted in China Medical University Hospital.A total of 10 subjects were enrolled, and all subjects applied FR-101 dressing. No one experienced adverse events during the study period. Efficacy evaluation revealed that 40% patients showed visible differences between the affected breast skin and the healthy breast skin. FR-101 dressing application may increase moisture and oil level of the affected breast skin, P = 0.08 and P = 0.01, respectively. Results of comparisons between the affected breast skin and the healthy breast skin showed a trend to improve breast sensitivity. (P = 0.08) CONCLUSION: Our findings demonstrate FR-101 dressing is a novel, safe, and feasible dressing for breast cancer patients undergoing whole breast radiotherapy. This pilot study also suggests that FR-101 dressing may promote the repair of the damaged skin appendages after radiotherapy and alleviate their radiation-irritated skin symptoms.