Green Tea Extract (Polyphenon E) in Preventing Cancer in Healthy Participants
RATIONALE: Green tea extract (Polyphenon E) contains ingredients that may prevent the development of cancer.
PURPOSE: This phase I trial is studying how well green tea extract works in preventing cancer in healthy participants.
|Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: defined green tea catechin extract||Phase 1|
|Study Design:||Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase I Drug Interaction Clinical Study of Polyphenon E|
|Study Start Date:||October 2004|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
- Determine the effect of green tea extract (Polyphenon E) on cytochrome P450 enzyme activities and glutathione S-transferase activities and levels in healthy participants.
- Determine the safety and tolerability of this drug in these participants.
OUTLINE: This is an open-label study.
Participants receive oral green tea extract (Polyphenon E) once daily for 4 weeks in the absence of unacceptable toxicity.
Participants are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 44 participants will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091325
|United States, Arizona|
|Arizona Cancer Center at University of Arizona Health Sciences Center|
|Tucson, Arizona, United States, 85724|
|Principal Investigator:||H. H. Sherry Chow, PhD||University of Arizona|