Chemoprevention of Lung Carcinogenesis Using Green Tea: Phase IIb Randomized, Double-Blinded, Placebo Controlled Trial of Green Tea and Polyphenon E in Former Smokers With Chronic Obstructive Lung Disease (COPD)
Chemoprevention of Lung Carcinogenesis Using Green Tea: Phase IIb Randomized, Double-Blinded, Placebo Controlled Trial of Green Tea and Polyphenon E in Former Smokers With Chronic Obstructive Lung Disease (COPD)
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 with chronic obstructive pulmonary disease.
PURPOSE: This randomized phase II trial is studying how well green tea or polyphenon E work in preventing lung cancer in former smokers with chronic obstructive pulmonary disease.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and inhaled steroid usage (yes vs no).
All patients receive placebo tea beverage and placebo capsules 4 times a day for 2 weeks. Patients are randomized to 1 of 3 treatment arms after successful completion of the 2-week period.
Patients undergo blood, urine, exhaled breath condensate (EBC), induced sputum, and buccal cell collection at baseline and periodically during study for biomarker/laboratory analysis. Blood samples are analyzed for 8-hydroxydeoxyguanosine (8-OHdG), glutathione peroxidase, and catalase. Urine is examined for F_2-isoprostanes, 8-OHdG, and tea polyphenols. Induced sputum broncho-epithelial cells are analyzed for gene expression of genes implicated in cellular growth and apoptotic pathway via reverse transcriptase-polymerase chain reaction. EBC samples are examined for F_2-isoprostane levels. Buccal cells are stored for future analysis.
PROJECTED ACCRUAL: A total of 195 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Diagnosis of chronic obstructive pulmonary disease
History of smoking ≥ 1 pack daily for 30 years OR 2 packs daily for 15 years
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:
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:
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