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

January 15, 2010 updated by: University of Arizona

Phase I Drug Interaction Clinical Study of Polyphenon E

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Healthy individuals

    • Non-smokers

      • More than 1 year since smoking cessation
      • No concurrent smokers

    • No regular consumption of large amounts of alcohol

      • On average, ≤ 3 alcoholic drinks per week
  • Consumes < 6 cups or glasses of tea per week

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance Status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin ≤ 2.0 mg/dL
  • AST or ALT ≤ 2 times normal
  • Alkaline phosphatase ≤ 2 times normal

Renal

  • Creatinine ≤ 1.5 mg/dL

Cardiovascular

  • Resting systolic blood pressure ≥ 100 mm Hg
  • No hypertension or hypercholesterolemia requiring unscheduled medical visits or changes in treatment within the past 3 months

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to refrain from tea and related products and oral herbal/botanical supplements during study participation
  • Willing to limit the consumption of cruciferous vegetables to ≤ once a week during study participation
  • Willing to refrain from caffeine-containing food or beverages (e.g., coffee, colas, chocolate, or over-the-counter medications) for 72 hours before, during, and for 8 hours after study drug administration
  • Willing to refrain from food items that affect drug or carcinogen metabolizing enzymes (e.g., grapefruit, grapefruit juice, cruciferous vegetables, and food cooked over charcoal) for 72 hours before, during, and for 8 hours after study drug administration
  • No difficulty swallowing capsules or tablets
  • No metabolic disorder known to affect study drugs
  • No other serious acute or chronic disease (e.g., type I or II diabetes, cystic fibrosis, or active infection)
  • No known hypersensitivity to green tea or probe drugs (e.g., caffeine, dextromethorphan, losartan, or buspirone)
  • No invasive cancer (i.e., non-skin cancer) within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 3 months since prior participation in another clinical intervention study
  • No concurrent medications or supplements that are known P450 enzyme inducers or inhibitors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: H. H. Sherry Chow, PhD, University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

September 7, 2004

First Submitted That Met QC Criteria

September 8, 2004

First Posted (Estimate)

September 9, 2004

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 15, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000387801
  • P30CA023074 (U.S. NIH Grant/Contract)
  • UARIZ-HSC-0499

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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