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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sherry Chow
• Collaborator: National Cancer Institute (NCI)

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