Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

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

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 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.

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 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.

Eligibility: 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

Relevance to patient case: not relevant