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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00091325
First received: September 7, 2004
Last updated: January 15, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Dietary Supplement: defined green tea catechin extract
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase I Drug Interaction Clinical Study of Polyphenon E

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Study Start Date: October 2004
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091325

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: H. H. Sherry Chow, PhD University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: H. H. Sherry Chow, Arizona Cancer Center at University of Arizona Health Sciences Center
ClinicalTrials.gov Identifier: NCT00091325     History of Changes
Other Study ID Numbers: CDR0000387801, P30CA023074, UARIZ-HSC-0499
Study First Received: September 7, 2004
Last Updated: January 15, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Arizona:
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on November 27, 2014