Green Tea Extract (Polyphenon E) in Preventing Cancer in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT00091325|
Recruitment Status : Completed
First Posted : September 9, 2004
Last Update Posted : January 20, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: defined green tea catechin extract||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase I Drug Interaction Clinical Study of Polyphenon E|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||March 2005|
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 ClinicalTrials.gov identifier (NCT number): 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|