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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00091325
Recruitment Status : Completed
First Posted : September 9, 2004
Last Update Posted : January 20, 2010
Sponsor:
Collaborator:
Information provided by:

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.


Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: defined green tea catechin extract Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Drug Interaction Clinical Study of Polyphenon E
Study Start Date : October 2004
Primary Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: H. H. Sherry Chow, PhD University of Arizona
More Information

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 ( U.S. NIH Grant/Contract )
UARIZ-HSC-0499
First Posted: September 9, 2004    Key Record Dates
Last Update Posted: January 20, 2010
Last Verified: January 2010

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

Additional relevant MeSH terms:
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents