Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pu… (NCT00363805) | Clinical Trial Compass
CompletedPhase 2
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
United States178 participantsStarted 2004-05
Plain-language 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …