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

Primary Purpose

Breast Neoplasms, Dermatitis, Prevention & Control

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
EGCG
placebo
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast Neoplasms, prevention & control, Epigallocatechin gallate, Dermatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    EGCG group

    placebo

    Arm Description

    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.

    The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Superiority of EGCG in reducing pain as assessed by the Skin Toxicity Assessment Tool (STAT) in patients with breast cancer receiving radiation
    Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer
    questionnaire

    Full Information

    First Posted
    September 27, 2015
    Last Updated
    April 3, 2019
    Sponsor
    Shandong Cancer Hospital and Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02580279
    Brief Title
    Study of Epigallocatechin-3-gallate (EGCG) for Skin Prevention in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
    Official Title
    Phase II Study of Topical Epigallocatechin-3-gallate (EGCG) in Patients With Breast Cancer Receiving Adjuvant Radiotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    August 2019 (Anticipated)
    Study Completion Date
    October 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shandong Cancer Hospital and Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Neoplasms, Dermatitis, Prevention & Control, Epigallocatechin Gallate
    Keywords
    Breast Neoplasms, prevention & control, Epigallocatechin gallate, Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    68 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EGCG group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo is 0.9% saline solution.Patients are also to follow general good skin care practices which is same as the EGCG group.
    Intervention Type
    Drug
    Intervention Name(s)
    EGCG
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Improved quality of life with usage of EGCG for treatment of radiation-dermatitis in patient with breast cancer
    Description
    questionnaire
    Time Frame
    Each patient will be enrolled for a 5-6 week trial

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ligang Xing, MD,PhD
    Organizational Affiliation
    Shandong Cancer Hospital and Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35648426
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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