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Phase Ⅰ,ⅡStudy of Topically Applied Green Tea Extract for Prevention and Treatment of Radio Dermatitis and Radiation Mucositis


Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling by invite only)
Both
Epigallocatechin Gallate, Radio Dermatitis, Radiation Mucositis

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Trial Information

Phase Ⅰ,ⅡStudy of Topically Applied Green Tea Extract for Prevention and Treatment of Radio Dermatitis and Radiation Mucositis


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Number of Participants with Adverse Events

Outcome Time Frame:

participants will be followed for the duration of radiotherapy, an expected average of 6 weeks").

Safety Issue:

Yes

Principal Investigator

Jinming Yu, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Shandong Cancer Hospital and Institute

Authority:

China: Food and Drug Administration

Study ID:

GTERD2011

NCT ID:

NCT01481818

Start Date:

September 2011

Completion Date:

April 2012

Related Keywords:

  • Epigallocatechin Gallate
  • Radio Dermatitis
  • Radiation Mucositis
  • Dermatitis
  • Radiodermatitis
  • Mucositis

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