Status:
COMPLETED
Green Tea Extract (Polyphenon E) in Preventing Cancer in Healthy Participants
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 can...
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. Seco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00091325
Start Date
October 1 2004
Last Update
January 20 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724