Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease

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