Clinical trial · Interventional
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| green tea | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| Polyphenon E | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Green Tea
- description
- Patients receive green tea beverage and placebo capsules for 6 months.
- interventionNames
- Dietary Supplement: green tea
- type
- EXPERIMENTAL
- label
- Polyphenon E
- description
- Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
- interventionNames
- Drug: Polyphenon E
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients receive placebo beverage and placebo capsules daily for 6 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available