Lung Cancer Prevention Clinical Trial
Official title:
Chemoprevention of Lung Carcinogenesis Using Green Tea: Phase IIb Randomized, Double-Blinded, Placebo Controlled Trial of Green Tea and Polyphenon E in Former Smokers With Chronic Obstructive Lung Disease (COPD)
| Verified date | September 2013 |
| Source | University of Arizona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 178 |
| Est. completion date | |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 80 Years |
| 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| United States | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona |
| United States | Veterans Affairs Medical Center - Tucson | Tucson | Arizona |
| United States | Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Sherry Chow | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Urinary 8-hydroxydeoxyguanosine Levels | the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels | Baseline and 6 months | No |
| Primary | Change in Urinary 8-F2-isoprostanes Levels | the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels | Baseline and 6 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02719860 -
High Tea Consumption on Smoking Related Oxidative Stress
|
Phase 2 |