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 range
40 Years – 80 Years
Sex
ALL
See this in plain English?
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.