Green Tea Extract (Polyphenon E) in Preventing Cancer in Healthy Participants - Full Text View

Sponsors and Collaborators:	University of Arizona National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00091325

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	Drug: defined green tea catechin extract	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Epigallocatechin gallate Catechin

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 2004

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

H. H. Sherry Chow, PhD

University of Arizona

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000387801, UARIZ-HSC-0499
Study First Received:	September 7, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00091325
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Epigallocatechin gallate
Healthy

ClinicalTrials.gov processed this record on January 14, 2009