Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
Last Modified: 4/3/2009 First Published: 8/6/2006
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 | Protocol IDs |
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| Phase II | Biomarker/Laboratory analysis, Prevention | Active | 40 to 80 | 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. 5
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 6 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 7.
Trial Contact Information
Trial Lead Organizations Arizona Cancer Center at University of Arizona Health Sciences Center  | | | | Iman Hakim, MD, PhD, MPH, Principal investigator | | | |
Trial Sites
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| U.S.A. |
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| Arizona |
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Tucson |
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| | | | | | | | | Arizona Cancer Center at University of Arizona Health Sciences Center |
| | | Clinical Trials Office - Arizona Cancer Center at University of Arizona Health Sciences Center | |
| | | Veterans Affairs Medical Center - Tucson |
| | | Iman Hakim | |
| | | Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea |
| | | Iman Hakim | |
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| 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 8 | | | Date Submitted to PDQ | | 2006-05-30 | | | Information Last Verified | | 2009-03-18 | | | NCI Grant/Contract Number | | CA101204, CA23074 |
Glossary Terms
abdomen (AB-doh-men)
The area of the body that contains the pancreas, stomach, intestines, liver, gallbladder, and other organs.
blood
A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.
cancer (KAN-ser)
A term for
diseases in which abnormal cells divide without control and
can invade nearby tissues. Cancer cells can also spread to
other parts of the body through the blood and lymph
systems. There are several main types of cancer. Carcinoma
is cancer that begins in the skin or in tissues that line
or cover internal organs. Sarcoma is cancer that begins in
bone, cartilage, fat, muscle, blood vessels, or other
connective or supportive tissue. Leukemia is cancer that
starts in blood-forming tissue such as the bone marrow, and
causes large numbers of abnormal blood cells to be produced
and enter the blood. Lymphoma and multiple myeloma are
cancers that begin in the cells of the immune system.
Central nervous system cancers are cancers that begin in
the tissues of the brain and spinal cord.
capsule (KAP-sool)
In medicine, a sac of tissue and blood vessels that surrounds an organ, joint, or tumor. A capsule is also a form for medicine that is taken by mouth. It usually has a shell made of gelatin with the medicine inside.
chemoprevention (KEE-moh-pree-VEN-shun)
The use of drugs, vitamins, or other agents to try to reduce the risk of, or delay the development or recurrence of, cancer.
chronic obstructive pulmonary disease (KRAH-nik ob-STRUK-tiv PUL-muh-NAYR-ee dih-ZEEZ)
A type of lung disease marked by permanent damage to tissues in the lungs, making it hard to breathe. Chronic obstructive pulmonary disease includes chronic bronchitis, in which the bronchi (large air passages) are inflamed and scarred, and emphysema, in which the alveoli (tiny air sacs) are damaged. It develops over many years and is usually caused by cigarette smoking. Also called COPD.
dietary supplement (DY-uh-TAYR-ee SUH-pleh-ment)
A product that is added to the diet. A dietary supplement is taken by mouth, and usually contains one or more dietary ingredient (such as vitamin, mineral, herb, amino acid, and enzyme). Also called nutritional supplement.
eligibility criteria (EH-lih-jih-BIH-lih-tee kry-TEER-ee-uh)
In clinical trials, requirements that must be met for an individual to be included in a study. These requirements help make sure that patients in a trial are similar to each other in terms of specific factors such as age, type and stage of cancer, general health, and previous treatment. When all participants meet the same eligibility criteria, it gives researchers greater confidence that results of the study are caused by the intervention being tested and not by other factors.
herbal (ER-bul)
Having to do with plants.
laboratory study
Research done in a laboratory. These studies may use test tubes or animals to find out if a drug, procedure, or treatment is likely to be useful. Laboratory studies take place before any testing is done in humans.
lung cancer (lung KAN-ser)
Cancer that forms in tissues of the lung, usually in the cells lining air passages. The two main types are small cell lung cancer and non-small cell lung cancer. These types are diagnosed based on how the cells look under a microscope.
phase II trial
A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.
placebo
An inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
Polyphenon E (PAH-lee-FEE-nun ...)
A substance being studied in the prevention of cancer. It is made from decaffeinated green tea, and contains chemicals called catechins, which are antioxidants. Also called green tea extract.
randomized clinical trial
A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.
sputum (SPYOO-tum)
Mucus and other matter brought up from the lungs by coughing.
surgery (SER-juh-ree)
A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.
tissue (TISH-oo)
A group or layer of cells that work together to perform a specific function.
urine (YOOR-in)
Fluid containing water and waste products. Urine is made by the kidneys, stored in the bladder, and leaves the body through the urethra.
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Table of Links
| 1 | http://www.cancer.gov/clinicaltrials/learning |
| 2 | http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials |
| 3 | http://www.cancer.gov/clinicaltrials/learning/questions-to-ask-about-participat
ing |
| 4 | http://www.nlm.nih.gov/medlineplus/druginformation.html |
| 5 | http://www.cancer.gov/clinicaltrials/UARIZ-HSC-0353#EntryCriteria_CDR0000487501 |
| 6 | http://www.cancer.gov/clinicaltrials/UARIZ-HSC-0353 |
| 7 | http://cancer.gov/clinicaltrials |
| 8 | http://clinicaltrials.gov/ct/show/NCT00363805 |
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