Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01481818
Recruitment Status : Enrolling by invitation
First Posted : November 30, 2011
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Han Xi Zhao, Shandong Cancer Hospital and Institute

Tracking Information
First Submitted Date  ICMJE November 23, 2011
First Posted Date  ICMJE November 30, 2011
Last Update Posted Date April 28, 2020
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2011)
Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks"). ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2011)
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"). ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Topically Applied Green Tea Extract for Radio Dermatitis and Radiation Mucositis
Official Title  ICMJE Phase Ⅰ,ⅡStudy of Topically Applied Green Tea Extract for Prevention and Treatment of Radio Dermatitis and Radiation Mucositis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Epigallocatechin Gallate
  • Radio Dermatitis
  • Radiation Mucositis
Intervention  ICMJE Drug: EGCG
Apply about 0.05ml/cm2 EGCG with different concentration topically for 3 times a day during radiotherapy
Study Arms  ICMJE Experimental: radioprotector
Intervention: Drug: EGCG
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: November 27, 2011)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01481818
Other Study ID Numbers  ICMJE GTERD2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Han Xi Zhao, Shandong Cancer Hospital and Institute
Study Sponsor  ICMJE Shandong Cancer Hospital and Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jinming Yu, M.D. Shandong Cancer Hospital and Institute
PRS Account Shandong Cancer Hospital and Institute
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP