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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. Identifier: NCT01481818
Recruitment Status : Enrolling by invitation
First Posted : November 30, 2011
Last Update Posted : April 28, 2020
Information provided by (Responsible Party):
Han Xi Zhao, Shandong Cancer Hospital and Institute

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 .

Condition or disease Intervention/treatment Phase
Epigallocatechin Gallate Radio Dermatitis Radiation Mucositis Drug: EGCG Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase Ⅰ,ⅡStudy of Topically Applied Green Tea Extract for Prevention and Treatment of Radio Dermatitis and Radiation Mucositis
Study Start Date : September 2011
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: radioprotector Drug: EGCG
Apply about 0.05ml/cm2 EGCG with different concentration topically for 3 times a day during radiotherapy

Primary Outcome Measures :
  1. 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 Measures :
  1. 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"). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01481818

Sponsors and Collaborators
Shandong Cancer Hospital and Institute
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Study Director: Jinming Yu, M.D. Shandong Cancer Hospital and Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Han Xi Zhao, M.D., Shandong Cancer Hospital and Institute Identifier: NCT01481818    
Other Study ID Numbers: GTERD2011
First Posted: November 30, 2011    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Skin Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Radiation Injuries
Wounds and Injuries