Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
Condition: Lung Cancer Prevention
MeSH terms: Lung Neoplasms
Intervention: green tea; Polyphenon E; placebo
Intervention description: Given orally; Given orally; Given orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 178.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: lung cancer; prevention; green tea; former smokers

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.
    

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