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

NCT02580279 | Unknown Phase 2

• 1 other identifier: GTEBC-2015
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms; Dermatitis; Prevention & Control; Epigallocatechin Gallate

Keywords

Breast Neoplasms; prevention & control; Epigallocatechin gallate; Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

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

Study Arms (2)

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.

Drug: EGCG

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.

Drug: placebo

Interventions

EGCG DRUG

EGCG group

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Related Publications (2)

• 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.

  PMID: 37620508 DERIVED

• 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.

  PMID: 35648426 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Dermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ligang Xing, MD,PhD

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2015
• First Posted: October 20, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 5, 2019

Record last verified: 2019-04