Status:
COMPLETED
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Sherry Chow
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer Prevention
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea or polyphenon E may prevent cancer from forming in former smokers...
Detailed Description
OBJECTIVES: Primary * Evaluate the effects of high-level oral consumption of defined green tea (four 12-oz servings/day) or polyphenon E capsules (4 capsules/day) on markers of cellular oxidative da...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of chronic obstructive pulmonary disease
- FEV\_1/FVC ≤ 78
- History of smoking ≥ 1 pack daily for 30 years OR 2 packs daily for 15 years
- Stopped smoking for ≥ 1 year
- No previously diagnosed bronchiectasis
- No history of \> 1 acute emphysema exacerbation within the past 3 months
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,500/mm³
- Platelet count \> 130,000/mm³
- Hemoglobin ≥ 11 g/dL (female) or 12 g/dL (male)
- AST and ALT normal
- Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease present)
- Creatinine ≤ 1.5 mg/dL
- Alkaline phosphatase ≤ 2 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No invasive cancer within the past 5 years
- Able and willing to consume caffeinated beverages
- Able to produce induced sputum
- Able to perform forced expiratory maneuver during spirometry testing
- No immunosuppression by virtue of medication or disease including, but no limited to, any of the following:
- Organ transplantation
- Liver or kidney failure
- Autoimmune diseases
- Oral steroids
- Chemotherapy
- No serious concurrent illness that could preclude study compliance, such as uncontrolled high blood pressure, heart disease, or poorly controlled diabetes
- No myocardial infarction within the past 6 weeks
- PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior and no concurrent dietary supplements or herbal products, including any of the following:
- Herbal tea
- Ginkgo biloba \> 60 mg/day
- Melatonin \> 3 mg/day
- Echinacea \> 300 mg/day
- Hypericum perforatum (St. John's wort) \> 300 mg/day
- DHEA mustard \> 5 mg/day
- At least 2 weeks since prior and no concurrent nontrial tea or tea products
- More than 3 weeks since prior chest or abdominal surgery
- More than 3 months since prior participation in chemoprevention or clinical intervention trials
- At least 3 months since prior and no concurrent megadoses of vitamins, defined as \> 4,000 IU of vitamin A, 400 IU of vitamin E, 400 IU of cholecalciferol (vitamin D), 60 μg of selenium, or 1,000 mg of ascorbic acid (vitamin C) per day
- No regular consumption of ≥ 6 cups or glasses of tea per week
- No concurrent nontrial caffeine at \> 1 serving/day (1 serving defined as 12 oz of regular soda or 8 oz of coffee)
- No concurrent participation in another interventional clinical trial
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT00363805
Start Date
May 1 2004
Last Update
November 28 2013
Active Locations (3)
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1
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Tucson, Arizona, United States, 85258
2
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
3
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024