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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of Defined Green Tea Catechin Extract in Former or Current Heavy Smokers With Abnormal Sputum Score

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Prevention Active 45 to 74 NCI BCCA-H03-61083 H03-61083, BCCA-R03-1083, NCT00573885

Trial Description

Purpose:

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

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

Eligibility:

Eligibility criteria include the following:

• 45-74 years old
• Current smokers who have smoked at least one pack a day for 30 years or more (closed to new patients as of 03/22/2006)
• Former smokers who have smoked at least one pack a day for 30 years or more
• Has an abnormal sputum score
• No carcinoma in situ or invasive cancer of the lung
• Drinks no more than five cups of tea a week
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Some patients will receive green tea extract by mouth twice a day for 2 months. They will also inhale budesonide twice a day in month 2. Patients will undergo bronchoscopy with biopsies and collection of cells from the mouth, bronchi, and alveoli at the end of months 1 and 2. (Closed to new patients as of 03/22/2006.)

Other patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive green tea extract twice a day for 6 months.

Patients in group two will receive a placebo by mouth twice a day for 6 months. Some patients may then receive green tea extract.

Patients will undergo bronchoscopy with biopsies and collection of cells from the mouth, bronchi, and alveoli at the end of months 6 and 12. Blood samples will also be collected periodically for laboratory studies.

After finishing treatment, patients will be evaluated periodically for 6 months.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

British Columbia Cancer Agency - Vancouver Cancer Centre

Stephen Lam, MD, Protocol chair		Ph: 604-877-6000; 800-663-3333

Canada
British Columbia
	Vancouver
	British Columbia Cancer Agency - Vancouver Cancer Centre
		Stephen Lam, MD	Ph:  604-877-6000 800-663-3333

Registry Information
Official Title		Phase II Trial of Polyphenon E in Former Smokers with Abnormal Sputa
Trial Start Date		2008-01-28
Trial Completion Date		2008-07-19 (estimated)
Registered in ClinicalTrials.gov		NCT00573885
Date Submitted to PDQ		2007-11-16
Information Last Verified		2008-04-06
NCI Grant/Contract Number		CA096964