Amelioration of Acute Radiation Dermatitis in Breast Cancer Patients by a Bioadhesive Barrier-Forming Gel (Episil): A Single-Center, Open, Parallel, Randomized, Phase I/II Controlled Trial.

Abstract

Episil is a bioadhesive barrier-forming liquid gel that can relieve mucositis caused by radiotherapy (RT) and effectively relieve pain. The purpose of this trial is to compare the efficacy and safety of Episil in improving acute radiation dermatitis (ARD) in patients with breast cancer. This study included patients who met the criteria for postoperative RT for breast cancer. The primary end point was the grade of RD during treatment. A total of 102 patients were included in this study. The patients were grouped in a 2:1 ratio using the randomized number table method: 67 patients received Episil combined with conventional skin care (the Episil group), whereas the remaining 35 patients served as the control group and received conventional skin care only (the control group). According to the grading criteria of the Radiation Therapy Oncology Group (RTOG), the skin reaction rate and severity were significantly better in the Episil group than the control group (24.62%, 72.31%, 3.08, 0, 0 vs. 0, 85.71%, 14.29%, 0, 0, 0) across grades 0 to 4 (P < 0.05). The itchiness score exhibited s significant reduction in the Episil group as compared with the control group (P < 0.05). The results of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) showed that the overall health (z = -5.855, P < 0.001) and overall quality of life (z = -6.583, P < 0.001) were better in the Episil group than the control group after RT. Overall, in patients with breast cancer receiving RT, the topical application of Episil may significantly reduce the grading of ARD, alleviate patient symptoms, and improve the patient's overall quality of life.