Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
Summary
The investigators conduct this phase II study of EGCG therapy protection of the skin from damage induced by radiotherapy in breast cancer. In order to observe the effectiveness of EGCG, investigators will utilize both clinician assessments and patient self-assessments. Physician's skin assessments will be scored utilizing the Radiation Therapy Oncology Group (RTOG) score. Patient reported symptom scores are adapted from the Skin Toxicity Assessment Tool (STAT) as pain, burning, itching, pulling, and tenderness in the treatment area. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.
Timeline
- Start
- 2014-12
- Primary completion
- 2019-08
- Completion
- 2019-10
Outcome
Met primary endpoint
paper The occurrence of grade 2 or worse RID was significantly lower (50.5%; 95% CI, 41.2%-59.8%) in the EGCG group than in the placebo group PMID 35648426 ↗
paper (P = .008). PMID 35648426 ↗
Publications
- Xie J, Jia L, Xie P, Yin X, Zhu W, Zhao H, Wang X, Meng X, Xing L, Zhao H, Li X. Efficacy and safety of epigallocatechin-3-gallate in treatment acute severe dermatitis in patients with cancer receiving radiotherapy: a phase I clinical trial. Sci Rep. 2023 Aug 24;13(1):13865. doi: 10.1038/s41598-023-40881-4.
- Zhao H, Zhu W, Zhao X, Li X, Zhou Z, Zheng M, Meng X, Kong L, Zhang S, He D, Xing L, Yu J. Efficacy of Epigallocatechin-3-Gallate in Preventing Dermatitis in Patients With Breast Cancer Receiving Postoperative Radiotherapy: A Double-Blind, Placebo-Controlled, Phase 2 Randomized Clinical Trial. JAMA Dermatol. 2022 Jul 1;158(7):779-786. doi: 10.1001/jamadermatol.2022.1736.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epigallocatechin-3-gallate | Unknown | — | Topical |