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

Sherry Chow178 enrolled

Overview

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 * 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 damage, as measured by 8-hydroxydeoxyguanosine (8-OHdG) and 8-F\_2-isoprostanes (8-epi-PGF2) in former smokers with chronic obstructive pulmonary disease. Secondary * Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on body antioxidant status (carotenoids, vitamins A and E, ascorbic acid \[vitamin C\] and antioxidant enzymes \[catalase and glutathione peroxidase\]) in blood in these patients. * Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on gene expression of markers of proliferation and apoptosis in induced sputum in these patients. Tertiary * Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on lung function in these patients. * Evaluate the relative adherence to use of green tea beverage vs polyphenon E capsules in these patients. 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. * Arm I (green tea beverage): Patients receive oral green tea beverage and oral polyphenon E placebo daily for 6 months. * Arm II (green tea capsule \[polyphenon E\]): Patients receive oral green tea beverage placebo and oral polyphenon E daily for 6 months. * Arm III (placebo): Patients receive oral green tea beverage placebo and oral polyphenon E placebo daily for 6 months. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

178

Conditions

Lung Cancer Prevention

Interventions

green teaDIETARY_SUPPLEMENT

Given orally

Polyphenon EDRUG

Given orally

placeboOTHER

Given orally

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Tucson, Arizona, United States

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Change in Urinary 8-hydroxydeoxyguanosine Levels

the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels

Time frame: Baseline and 6 months

Change in Urinary 8-F2-isoprostanes Levels

the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels

Time frame: Baseline and 6 months

Data from ClinicalTrials.gov

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