IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
Last Modified: 11/2/2007  First Published: 12/22/2004
Alternate Title Basic Trial Information Trial Description Purpose Eligibility Treatment/Intervention Trial Contact Information Registry Information
Alternate Title
Phase I Pilot Chemoprevention Study of IH636 Grape Seed Proanthocyanidin Extract in Healthy Postmenopausal Women at High Risk of Developing Breast Cancer
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase I | Prevention | Active | 40 to 75 | CHNMC-IRB-03178 NCT00100893 |
Special Category:
NCI Avon award trial Trial Description Purpose: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer.
This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer. Eligibility: Eligibility criteria include the following: Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Treatment/Intervention: Participants will receive placebo by mouth once or twice a day for 2 weeks. They will then receive IH636 grape seed extract by mouth once or twice a day for up to 3 months.
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 City of Hope Comprehensive Cancer Center | | | Clinical Trials Office - New Patient Services | | | | Trial Sites
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U.S.A. |
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California |
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Duarte |
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| | | | | | | | City of Hope Comprehensive Cancer Center |
| | Clinical Trials Office - City of Hope Comprehensive Cancer Center | |
| Email:
becomingapatient@coh.org |
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Registry Information | | Official Title | | A Phase I Prevention Trial of ACTIVINTM Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer | | Trial Start Date | | 2005-01-14 | | Trial Completion Date | | 2008-05-30 (estimated) | | Registered in ClinicalTrials.gov | | NCT00100893 8 | | Date Submitted to PDQ | | 2004-11-18 | | Information Last Verified | | 2007-04-06 | | NCI Grant/Contract Number | | CA33572 |
Glossary Terms
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.
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.
dose
The amount of medicine taken, or radiation given, at one time.
drug
Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.
ductal carcinoma in situ (DUK-tal KAR-sih-NOH-muh in SYE-too)
A noninvasive condition in which abnormal cells are found in the lining of a breast duct. The abnormal cells have not spread outside the duct to other tissues in the breast. In some cases, ductal carcinoma in situ may become invasive cancer and spread to other tissues, although it is not known at this time how to predict which lesions will become invasive. Also called DCIS and intraductal carcinoma.
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.
hormone therapy (HOR-mone THAYR-uh-pee)
Treatment that adds, blocks, or removes hormones. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body’s natural hormones. Sometimes surgery is needed to remove the gland that makes a certain hormone. Also called endocrine therapy, hormonal therapy, and hormone treatment.
IH636 grape seed extract
A substance being studied for its ability to prevent damage to normal tissue caused by radiation therapy. It is a type of antioxidant.
phase I trial
The first step in testing a new treatment in humans. These studies test the best way to give a new treatment (for example, by mouth, intravenous infusion, or injection) and the best dose. The dose is usually increased a little at a time in order to find the highest dose that does not cause harmful side effects. Because little is known about the possible risks and benefits of the treatments being tested, phase I trials usually include only a small number of patients who have not been helped by other treatments.
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.
postmenopausal (post-MEH-nuh-pawz-ul)
Having to do with the time after menopause. Menopause (“change of life”) is the time in a woman's life when menstrual periods stop permanently.
side effect
A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.
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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/CHNMC-IRB-03178#EntryCriteria_CDR0000407637 |
6 | http://www.cancer.gov/clinicaltrials/CHNMC-IRB-03178 |
7 | http://cancer.gov/clinicaltrials |
8 | http://clinicaltrials.gov/ct/show/NCT00100893 |
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