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

Study Overview
=================
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.

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.

Official Title
-----------------
Phase I Drug Interaction Clinical Study of Polyphenon E

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Dietary Supplement: defined green tea catechin extract


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: defined green tea catechin extract|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific