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: March 16, 2014
Last verified: March 2014
  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 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radioprotector 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 16, 2014
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 August 25, 2014