Status:
TERMINATED
Green Tea Extract in Treating Current or Former Smokers With Bronchial Dysplasia
Lead Sponsor:
British Columbia Cancer Agency
Collaborating Sponsors:
National Cancer Institute (NCI)
University of Cincinnati
Conditions:
Lung Cancer
Precancerous Condition
Eligibility:
All Genders
45-74 years
Phase:
PHASE2
Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Polyphenon E, a substance found in green tea, may keep cancer from forming in current or former smokers w...
Detailed Description
OBJECTIVES: Primary * To evaluate the efficacy and safety of Polyphenon E, a defined green tea catechin extract, in current or former smokers with bronchial dysplasia and increased inflammatory load...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Current or former smoker who has smoked ≥ 30 pack-years (i.e., 1 pack per day for ≥ 30 years)
- A former smoker is defined as one who has stopped smoking for ≥ 1 year
- C-reactive protein level \> 1.2 mg/L
- One or more areas of dysplasia with a surface diameter \> 1.2 mm on autofluorescence bronchoscopy
- No carcinoma in situ or invasive cancer on bronchoscopy
- No abnormal spiral chest CT scan suspicious of lung cancer
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Willing to take Polyphenon E or placebo twice a day regularly
- Willing to undergo bronchoscopy and spiral chest CT scan
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine normal
- Bilirubin normal
- AST and ALT normal
- Alkaline phosphatase normal
- No chronic active hepatitis or liver cirrhosis
- No severe heart disease (e.g., unstable angina or chronic congestive heart failure)
- No ongoing gastric ulcer
- No acute bronchitis or pneumonia within the past month
- No known reaction to xylocaine, salbutamol, midazolam, or alfentanil
- No known allergy to green tea and/or corn starch, gelatin, or other nonmedicinal ingredients
- No medical condition, such as acute or chronic respiratory failure or bleeding disorder, that, in the opinion of the investigator, could jeopardize patient safety during study participation
- PRIOR CONCURRENT THERAPY:
- No concurrent consumption of \> 7 cups of tea a week
- No other concurrent natural health products containing green tea compounds
- No concurrent antiarrhythmic agents
- No concurrent anticoagulants, such as warfarin or heparin
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00611650
Start Date
October 1 2006
End Date
July 1 2011
Last Update
March 9 2012
Active Locations (1)
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1
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6