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

Phase 2

• Conditions: Dermatitis; Prevention & Control; Epigallocatechin Gallate; Breast Neoplasms
• Interventions: Drug: placebo; Drug: EGCG

• Registration Number: NCT02580279
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-09-27
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05
• Primary Completion: 2019-08
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	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.
EGCG group	EGCG	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer	Each patient will be enrolled for a 5-6 week trial	questionnaire
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