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
About this trial
This is an interventional prevention trial for Epigallocatechin Gallate
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
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
NCT ID
NCT01481818
First Posted
November 23, 2011
Last Updated
April 25, 2020
Sponsor
Shandong Cancer Hospital and Institute
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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