Green Tea Extract in Preventing Cancer in Former and Current Heavy Smokers With Abnormal Sputum

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea extract may keep cancer from forming.

PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in former and current heavy smokers with abnormal sputum.

• 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 smokers who have smoked at least 30 pack-years (e.g., 1 pack per day for 30 years or more) (part 1; completed March 22, 2006)

• Former smokers who have smoked at least 30 pack-years (part 2)

• A former smoker is defined as one who has stopped smoking for one or more years

• Abnormal sputum score ≥ 0.25 by computer-assisted image analysis

• Exhaled carbon monoxide level < 5 ppm (part 2 )

• Willing to take defined green tea catechin extract/placebo twice a day regularly

• No evidence of overt lung cancer

• No carcinoma in situ or invasive cancer on bronchoscopy or abnormal spiral chest CT suspicious of lung cancer

PATIENT CHARACTERISTICS:

Inclusion criteria:

• ECOG performance status 0-1

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Creatinine normal

• Bilirubin normal

• AST and ALT normal

• Alkaline phosphatase normal

Exclusion criteria:

• Chronic active hepatitis/liver cirrhosis

• Severe heart disease (e.g., unstable angina, chronic congestive heart failure, use of antiarrhythmic agents)

• Ongoing gastric ulcer

• Acute bronchitis or pneumonia within one month

• Known reaction to lidocaine, albuterol sulfate, midazolam hydrochloride, and/or alfentanil hydrochloride

• Known allergy to green tea and/or corn starch, gelatin, or other nonmedicinal ingredients

• Any medical condition, such as acute or chronic respiratory failure or bleeding disorder that, in the opinion of the investigator, could jeopardize the patient's safety during participation in the study

• Unwilling to have a bronchoscopy

• Unwilling to have a spiral chest CT

PRIOR CONCURRENT THERAPY:

• No more than 5 cups of tea a week

• No concurrent anticoagulant treatment such as warfarin or heparin

• No use of other natural health products containing green tea compounds