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
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): green tea; Polyphenon E; placebo
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): Given orally; Given orally; Given orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lung cancer; prevention; green tea; former smokers