Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
Lung Cancer Prevention
About this trial
This is an interventional prevention trial for Lung Cancer Prevention focused on measuring lung cancer, prevention, green tea, former smokers
Eligibility Criteria
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
Sites / Locations
- Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
- Veterans Affairs Medical Center - Tucson
- Arizona Cancer Center at University of Arizona Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Green Tea
Polyphenon E
Placebo
Patients receive green tea beverage and placebo capsules for 6 months.
Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
Patients receive placebo beverage and placebo capsules daily for 6 months.