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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Han Xi Zhao, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01481818
First received: November 23, 2011
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Epigallocatechin Gallate
Radio Dermatitis
Radiation Mucositis
 Drug: EGCG
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Shandong Cancer Hospital and Institute:

Primary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of radiotherapy, an expected average of 6 weeks"). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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"). ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: September 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: EGCG
    Apply about 0.05ml/cm2 EGCG with different concentration topically for 3 times a day during radiotherapy
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481818

Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
Study Director: Jinming Yu, M.D. Shandong Cancer Hospital and Institute
  More Information

No publications provided

Responsible Party: Han Xi Zhao, M.D., Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT01481818     History of Changes
Other Study ID Numbers: GTERD2011
Study First Received: November 23, 2011
Last Updated: January 27, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Dermatitis
Radiodermatitis
Mucositis
Skin Diseases
Radiation Injuries
Wounds and Injuries
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 22, 2013