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| Sponsor: | University of Kansas |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033345 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Indole-3-carbinol may be effective in preventing breast cancer.
PURPOSE: Phase I trial to study the effectiveness of indole-3-carbinol in preventing breast cancer in nonsmoking women who are at high risk for breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: indole-3-carbinol |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention |
| Official Title: | Multiple Daily Dose Phase I Safety And Pharmacokinetic Clinical Study Of Indole-3-Carbinol |
| Study Start Date: | January 2002 |
OBJECTIVES:
OUTLINE: This is a single-blind study.
Participants ingest study compound twice daily on weeks 1-12 or 1-16. Study compound is dispensed on weeks 1, 5, and 9. At times, study compound is oral placebo, and at other times, oral indole-3-carbinol.
Quality of life is assessed at baseline and then every 4 weeks during study therapy.
PROJECTED ACCRUAL: A total of 18 participants will be accrued for this study within 9 months.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Women at high risk for breast cancer, defined by at least 1 of the following criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7320 | |
| Study Chair: | Aryeh Hurwitz, MD | University of Kansas |
More Information
| Study ID Numbers: | CDR0000069276, KUMC-8508-01, NCI-P02-0217 |
| Study First Received: | April 9, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00033345 History of Changes |
| Health Authority: | United States: Federal Government |
|
breast cancer |
|
Anticarcinogenic Agents Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Breast Neoplasms Protective Agents Pharmacologic Actions Breast Diseases Indole-3-carbinol |