Spots Global Cancer Trial Database for Green Tea Extract (Polyphenon E) in Preventing Cancer in Healthy Participants

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Trial Identification

Brief Title: Green Tea Extract (Polyphenon E) in Preventing Cancer in Healthy Participants

Official Title: Phase I Drug Interaction Clinical Study of Polyphenon E

Study ID: NCT00091325

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

defined green tea catechin extract

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: Primary * Determine the effect of green tea extract (Polyphenon E) on cytochrome P450 enzyme activities and glutathione S-transferase activities and levels in healthy participants. Secondary * 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.