Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
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|ClinicalTrials.gov Identifier: NCT02580279|
Recruitment Status : Unknown
Verified April 2019 by Han Xi Zhao, Shandong Cancer Hospital and Institute.
Recruitment status was: Enrolling by invitation
First Posted : October 20, 2015
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Dermatitis Prevention & Control Epigallocatechin Gallate||Drug: EGCG Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: EGCG group
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 Comparator: placebo
The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group.
- 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 [ Time Frame: Each patient will be enrolled for a 5-6 week trial ]
- Superiority of EGCG in reducing pain as assessed by the Skin Toxicity Assessment Tool (STAT) in patients with breast cancer receiving radiation [ Time Frame: 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 [ Time Frame: Each patient will be enrolled for a 5-6 week trial ]questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580279
|Study Chair:||Ligang Xing, MD,PhD||Shandong Cancer Hospital and Institute|