Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy

Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms; Dermatitis; Prevention & Control; Epigallocatechin Gallate
• Intervention / Treatment: Drug: placebo; Drug: EGCG

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ eighteen years
• Eastern Cooperative Oncology Group performance status of 0-1
• Normal hematologic, hepatic function and renal values
• Forced expiratory volume 1 >800 cc

Exclusion Criteria:

• The presence of rash or unhealed wound in the radiation field
• A known allergy or hypersensitivity to EGCG
• Pregnancy or lactation
• History of/current connective tissue disorder
• Prior radiation to the thorax

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: EGCG
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.	Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	questionnaire	Each patient will be enrolled for a 5-6 week trial

Collaborators and Investigators

• Sponsor: Shandong Cancer Hospital and Institute
• Investigators: Study Chair: Ligang Xing, MD,PhD, Shandong Cancer Hospital and Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: September 27, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Breast Neoplasms; prevention & control; Epigallocatechin gallate; Dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Dermatitis
• Other Study ID Numbers: GTEBC-2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No