Prevention of Acute Radiation-Induced Skin Reaction with NPED Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study

Background. To assess efectiveness of NPE, a proprietary Camellia sinensis nonfermentatum (CSNF) extract, in prevention and recovery of acute radiation-induced skin reaction (ARSR) and skin care during postoperative whole breast radiotherapy (RT). Methods. Twenty patients were enrolled in this single centre, prospective, open-label pilot study. Te outcomes of 20 prospective data sets were compared with 100 retrospectively collected matched data sets derived from hospital records. Te preventive CSNF gel (2.5%) was administered 1 to 2 hours before each session on the irradiated felds. Te care CSNF lotion (0.4%) was administered as 7-day pretreatment afer each RT session, twice daily between RT sessions, and 4 to 8 weeks thereafer. Te control group was treated according to the hospital care guidelines. Te primary endpoint was time to ARSR ≥ Grade 2 (CTCAE v4.03); secondary endpoints were frequencies of ARSR grades 1, 2, 3, and 4, recovery of ARSR, frequencies of interruption and RT stop, complications and required rescue interventions, and tolerability of CSNF. Results. Time to ARSR ≥ G2 (censoring) was signifcantly longer (p = 0.014) in the CSNF group. Te hazard ratio was 2.33 (95% CI: 1.15–4.72), demonstrating a 50% decrease in the risk of developing ARSR ≥ G2. Tere was a trend to faster recovery from ARSR G2 in the CSNF group (100% versus 47%; p = 0.078). Te proportion of patients requiring rescue treatment during RT and follow-up was markedly higher in the control compared to the CSNF group (1% to 51% versus 0% to 15%). CSNF gel and lotion were well tolerated both during and afer RT. Conclusions. Tis pilot study provides the frst evidence on the potential pharmacological efectiveness of CSNF extract in prevention of RT-induced ARSR and recovery of skin irritation in patients undergoing postoperative whole breast RT and may refect a novel concept for prevention of RT-induced ARSR and care of irritated skin.