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

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00091325
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study First Submitted: 2004-09-07
• Study First Submitted QC: 2004-09-08
• Study First Posted: 2004-09-09
• Study Start: 2004-10
• Primary Completion: 2005-03
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-15
• Last Update Posted: 2010-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Arizona Cancer Center at University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States