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Study of Topically Applied Green Tea Extract for Radio Dermatitis and Radiation Mucositis

Primary Purpose

Epigallocatechin Gallate, Radio Dermatitis, Radiation Mucositis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
EGCG
Sponsored by
Shandong Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epigallocatechin Gallate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥18 years old
  • with histologically proven cancer
  • receive external radiotherapy or concurrent chemoradiotherapy

Exclusion Criteria:

  • previous radiotherapy
  • previous chemotherapy for another neoplasia
  • pregnancy or lactation
  • a known allergy or hypersensitivity to EGCG

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    radioprotector

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Participants with Adverse Events

    Secondary Outcome Measures

    Frequency and Severity of Radio Dermatitis or Radiation Mucositis during Radiotherapy

    Full Information

    First Posted
    November 23, 2011
    Last Updated
    April 25, 2020
    Sponsor
    Shandong Cancer Hospital and Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01481818
    Brief Title
    Study of Topically Applied Green Tea Extract for Radio Dermatitis and Radiation Mucositis
    Official Title
    Phase Ⅰ,ⅡStudy of Topically Applied Green Tea Extract for Prevention and Treatment of Radio Dermatitis and Radiation Mucositis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    August 2022 (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
    Radiodermatitis and radiation mucositis were the most frequent side-effect during the course of radiotherapy, especially when concurrent chemoradiotherapy applied. Since reactive oxygen species formed upon radiation therapy play a central role in initiating and driving the detrimental signaling events, antioxidant supplementation is thought to provide a photoprotective effect against radiation. Green tea extract has been shown to have antioxidant and anti-inflammatory effects on various types of cells. To evaluate the safety and efficiency of green tea extract in the treatment of radio dermatitis and radiation mucositis, the investigators conducted this phase Ⅰ,II study using topical EGCG in cancer patients receiving radiotherapy or concurrent chemoradiotherapy .
    Detailed Description
    The phase 1 trial using EGCG for prevention and treatment radiodermatitis in patients with breast cancer. Patient selection criteria The eligible criteria including: ≥18 years old; adequate renal and hepatic function; with histological proven breast cancer; receive adjuvant external electron beam RT to chest wall (with or without lymph nodes associated) after modified radical mastectomy; receive at least 50.0 Gy in 25~28 fractions, delivered daily, 5d/week; each treatment was planned using a simulated locator with the patient in the supine position and adequate immobilization. The exclusion criteria were as follows: previous RT to chest wall and/or lymph nodes associated; previous chemotherapy or radiotherapy for another neoplasia; pregnancy or lactation; concomitant chemotherapy; a known allergy or hypersensitivity to EGCG. Treatment Protocol Patients were instructed to apply about 0.01~0.05ml/cm2 EGCG 3 times a day to the area under treatment. The initial concentration is about 40μM, adjusted from previous study (Katiyar SK, Afaq F, Perez A, Mukhtar H. Green tea polyphenol (-)-epigallocatechin-3-gallate treatment of human skin inhibits ultraviolet radiation-induced oxidative stress. Carcinogenesis. 2001; 22(2):287-94) EGCG treatment begins when cutaneous toxicity reaches grade 1, evaluated by the principal investigator and the patient's radiation oncologist according to Radiation Therapy Oncology Group acute skin toxicity scale.The duration of EGCG treatment will last at least two weeks after RT completion, further use of EGCG was not encouraged. At per protocol, patients who developed grade Ⅱ radiation-induced dermatitis had the option to either withdraw from the study or to continue with EGCG.Adverse events more than grade 1 attributed to EGCG that did not respond to supportive care were considered dose-limiting toxicity (DLT). Transient toxicity more than grade 1 that responded to supportive care was recorded as an adverse event but was not considered dose limiting. In general, for grade 2 adverse events attributed to EGCG, therapy was held until symptoms resolved to ≤ grade 1 and then reinitiated along with supportive care measures at the same dose level. The maximum-tolerated dose (MTD) was defined as the dose level below the lowest dose that induced a DLT in at least one third of patients (at least two of six patients) after one cycle of therapy. Acute skin toxicity were evaluated using Radiation Therapy Oncology Group acute skin toxicity scale by principal investigator. The Skin Toxicity Assessment Tool was used to measure patient-reported discomforts. (Berthelet E, Truong PT, Musso K, et al. Preliminary reliability and validity testing of a new Skin Toxicity Assessment Tool (STAT) in breast cancer patients undergoing radiotherapy. Am J Clin Oncol 2004;27:626-631.). Statistical Analyses The primary outcome for this phase I trial was the number of DLTs and determination of the MTD, with frequency and severity of radiodermatitis the secondary outcome, frequency and severity of pain and pruritus the third outcome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epigallocatechin Gallate, Radio Dermatitis, Radiation Mucositis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    radioprotector
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    EGCG
    Intervention Description
    Apply about 0.05ml/cm2 EGCG with different concentration topically for 3 times a day during radiotherapy
    Primary Outcome Measure Information:
    Title
    Number of Participants with Adverse Events
    Time Frame
    participants will be followed for the duration of radiotherapy, an expected average of 6 weeks").
    Secondary Outcome Measure Information:
    Title
    Frequency and Severity of Radio Dermatitis or Radiation Mucositis during Radiotherapy
    Time Frame
    participants will be followed every weeks for the duration of radiotherapy, an expected average of 6 weeks").

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥18 years old with histologically proven cancer receive external radiotherapy or concurrent chemoradiotherapy Exclusion Criteria: previous radiotherapy previous chemotherapy for another neoplasia pregnancy or lactation a known allergy or hypersensitivity to EGCG
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jinming Yu, M.D.
    Organizational Affiliation
    Shandong Cancer Hospital and Institute
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24444526
    Citation
    Zhao H, Zhu W, Xie P, Li H, Zhang X, Sun X, Yu J, Xing L. A phase I study of concurrent chemotherapy and thoracic radiotherapy with oral epigallocatechin-3-gallate protection in patients with locally advanced stage III non-small-cell lung cancer. Radiother Oncol. 2014 Jan;110(1):132-6. doi: 10.1016/j.radonc.2013.10.014. Epub 2014 Jan 17.
    Results Reference
    derived

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    Study of Topically Applied Green Tea Extract for Radio Dermatitis and Radiation Mucositis

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