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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 Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Prevention	Active	40 to 80	NCI	UARIZ-HSC-0353 U01-CA-101204, NCT00363805

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• 40-80 years old
• Smoked at least one pack of cigarettes a day for 30 years or two packs a day for 15 years
• At least 1 year since quitting smoking
• At least 2 weeks since dietary supplements, herbal products, tea, or tea products
• More than 3 weeks since surgery to the chest or abdomen
• 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:

All patients will receive a placebo drink and a placebo capsule four times a day for 2 weeks. They will then be randomly assigned (have an equal chance of being placed) to one of three treatment groups.

Patients in group one will receive green tea drinks and placebo capsules each day. Treatment may continue for up to 6 months.

Patients in group two will receive placebo drinks and polyphenon E capsules each day. Treatment may continue for up to 6 months.

Patients in group three will receive placebo drinks and placebo capsules each day. Treatment may continue for up to 6 months.

Patients will undergo blood, urine, sputum, and tissue sample collection before beginning treatment and periodically for laboratory studies.

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

Arizona Cancer Center at University of Arizona Health Sciences Center

Iman Hakim, MD, PhD, MPH, Principal investigator		Ph: 520-626-5355; 800-622-2673 Email: ihakim@azcc.arizona.edu

U.S.A.
Arizona
	Tucson
	Arizona Cancer Center at University of Arizona Health Sciences Center
		Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center	Ph:  520-626-9008
	Veterans Affairs Medical Center - Tucson
		Iman Hakim	Ph:  5206265355
	Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
		Iman Hakim	Ph:  5206265355

Registry Information
Official Title		Chemoprevention of Lung Carcinogenesis Using Green Tea: Phase IIb Randomized, Double-Blinded, Placebo Controlled Trial of Green Tea and Polyphenon E in Former Smokers with Chronic Obstructive Lung Disease (COPD)
Trial Start Date		2004-05-01
Trial Completion Date		2009-03-15 (estimated)
Registered in ClinicalTrials.gov		NCT00363805
Date Submitted to PDQ		2006-05-30
Information Last Verified		2009-03-18
NCI Grant/Contract Number		CA101204, CA23074