Green Tea Extract in Treating Current or Former Smokers With Bronchial Dysplasia

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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 with bronchial dysplasia.

PURPOSE: This randomized phase II trial is studying the side effects and how well green tea extract works in treating current or former smokers with bronchial dysplasia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborators: National Cancer Institute (NCI); University of Cincinnati
• Treatments: Epigallocatechin gallate

Criteria

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