NCT00091325

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

Phase I Drug Interaction Clinical Study of Polyphenon E

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	defined green tea catechin extract

Timeline

• Start date: 2004-10-01
• Primary completion: 2005-03-01
• First posted: 2004-09-09
• Last updated: 2010-01-20

Locations

1 site across 1 country: United States