Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study
Background. To assess effectiveness 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 sing...
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| Format: | Article |
| Language: | English |
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Wiley
2018-01-01
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| Series: | International Journal of Breast Cancer |
| Online Access: | http://dx.doi.org/10.1155/2018/2479274 |
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| author | Gabriela Näf Urs E. Gasser Hans E. Holzgang Sandra Schafroth Christoph Oehler Daniel R. Zwahlen |
| author_facet | Gabriela Näf Urs E. Gasser Hans E. Holzgang Sandra Schafroth Christoph Oehler Daniel R. Zwahlen |
| author_sort | Gabriela Näf |
| collection | DOAJ |
| description | Background. To assess effectiveness 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. The outcomes of 20 prospective data sets were compared with 100 retrospectively collected matched data sets derived from hospital records. The preventive CSNF gel (2.5%) was administered 1 to 2 hours before each session on the irradiated fields. The care CSNF lotion (0.4%) was administered as 7-day pretreatment after each RT session, twice daily between RT sessions, and 4 to 8 weeks thereafter. The control group was treated according to the hospital care guidelines. The 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 significantly longer (p = 0.014) in the CSNF group. The hazard ratio was 2.33 (95% CI: 1.15–4.72), demonstrating a 50% decrease in the risk of developing ARSR ≥ G2. There was a trend to faster recovery from ARSR G2 in the CSNF group (100% versus 47%; p = 0.078). The 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 after RT. Conclusions. This pilot study provides the first evidence on the potential pharmacological effectiveness of CSNF extract in prevention of RT-induced ARSR and recovery of skin irritation in patients undergoing postoperative whole breast RT and may reflect a novel concept for prevention of RT-induced ARSR and care of irritated skin. |
| format | Article |
| id | doaj-art-de11ccc48015408b8aa0618dc25a4676 |
| institution | Kabale University |
| issn | 2090-3170 2090-3189 |
| language | English |
| publishDate | 2018-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | International Journal of Breast Cancer |
| spelling | doaj-art-de11ccc48015408b8aa0618dc25a46762025-02-03T05:52:34ZengWileyInternational Journal of Breast Cancer2090-31702090-31892018-01-01201810.1155/2018/24792742479274Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot StudyGabriela Näf0Urs E. Gasser1Hans E. Holzgang2Sandra Schafroth3Christoph Oehler4Daniel R. Zwahlen5Department of Radiation Oncology, Kantonsspital Graubünden, Chur, SwitzerlandClinResearch Ltd., Aesch, SwitzerlandNovelpharm Ltd., Schlieren, SwitzerlandNovelpharm Ltd., Schlieren, SwitzerlandDepartment of Radiation Oncology, Kantonsspital Graubünden, Chur, SwitzerlandDepartment of Radiation Oncology, Kantonsspital Graubünden, Chur, SwitzerlandBackground. To assess effectiveness 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. The outcomes of 20 prospective data sets were compared with 100 retrospectively collected matched data sets derived from hospital records. The preventive CSNF gel (2.5%) was administered 1 to 2 hours before each session on the irradiated fields. The care CSNF lotion (0.4%) was administered as 7-day pretreatment after each RT session, twice daily between RT sessions, and 4 to 8 weeks thereafter. The control group was treated according to the hospital care guidelines. The 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 significantly longer (p = 0.014) in the CSNF group. The hazard ratio was 2.33 (95% CI: 1.15–4.72), demonstrating a 50% decrease in the risk of developing ARSR ≥ G2. There was a trend to faster recovery from ARSR G2 in the CSNF group (100% versus 47%; p = 0.078). The 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 after RT. Conclusions. This pilot study provides the first evidence on the potential pharmacological effectiveness of CSNF extract in prevention of RT-induced ARSR and recovery of skin irritation in patients undergoing postoperative whole breast RT and may reflect a novel concept for prevention of RT-induced ARSR and care of irritated skin.http://dx.doi.org/10.1155/2018/2479274 |
| spellingShingle | Gabriela Näf Urs E. Gasser Hans E. Holzgang Sandra Schafroth Christoph Oehler Daniel R. Zwahlen Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study International Journal of Breast Cancer |
| title | Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study |
| title_full | Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study |
| title_fullStr | Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study |
| title_full_unstemmed | Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study |
| title_short | Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study |
| title_sort | prevention of acute radiation induced skin reaction with npe r camellia sinensis nonfermentatum extract in female breast cancer patients undergoing postoperative radiotherapy a single centre prospective open label pilot study |
| url | http://dx.doi.org/10.1155/2018/2479274 |
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