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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGCG group | Experimental | EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution;The solution is sprayed three times a day at 0.05 ml/cm2 to the whole radiation field until two weeks after radiation completion; Patients who developed grade Ⅱ radiation-induced dermatitis have the option to either withdraw from the study or to continue with EGCG. Patients are follow general good skin care practices during radiation therapy, such as not applying water soaks to relieve itching or pain, not vigorously rubbing the irradiated area, or not erasing ink marks; patting the skin dry with a soft towel; avoiding exposure to the sun; and wearing loose and cotton clothes. They are advised not to use deodorant, lotion, cream, make up, perfume or any other product on the area during the course of radiation therapy. |
|
| placebo | Placebo Comparator | The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGCG | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of EGCG in reducing Grade II or more dermatitis as assessed by Radiation Therapy Oncology Group (RTOG) scores in patients with breast cancer receiving radiation | Each patient will be enrolled for a 5-6 week trial |
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of EGCG in reducing pain as assessed by the Skin Toxicity Assessment Tool (STAT) in patients with breast cancer receiving radiation | Each patient will be enrolled for a 5-6 week trial | |
| Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ligang Xing, MD,PhD | Shandong Cancer Hospital and Institute | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37620508 | Derived | 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. | |
| 35648426 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2022 | |
| Reset | Jul 12, 2022 |
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|
questionnaire
| Each patient will be enrolled for a 5-6 week trial |
| 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2022 | Jul 12, 2022 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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