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Clinical Trial NU KUMC11B02

Title
Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer
Principal Investigator
Seema Khan
Details
  • Status: Accepting New Patients
  • Study Type: Prevention, Prevention
  • Protocol No:.NU KUMC11B02
Purpose
The purpose of this study is to determine if a natural compound derived from flaxseed (Brevail) can reduce breast cell growth in premenopausal women. Also, to see if women at increased risk for breast cancer are likely to tolerate SDG daily for 12 months without significant side effects or changes in their menstrual cycles.
Overview
Medications can help reduce breast cancer risk in women who are at increased risk of breast cancer for a variety of reasons, including a family history of breast or ovarian cancer, or a previous benign breast biopsy. However, medications can cause side effects whereas natural products may be safer. We are studying one such natural substance (SECO) in pre-menopausal women who are at increased risk for developing breast cancer. Lignans are a group of compounds found in edible plants which, after digestion, are converted to substances that decrease estrogen. An important plant lignan is secoisolariciresinol (SECO) found in highest concentration in flaxseed. . Early studies show that women who consume SECO will experience normalization of proteins in breast cells and in the blood that may indicate high risk for breast cancer (these are called risk biomarkers). This study is designed to gather information on how a specific form of lignan, secoisolariciresinol diglycoside (SDG), affects blood and tissue risk biomarkers for breast cancer.
Eligibility
Some of the eligibility criteria include:
  • Participants must not have taken, started or stopped oral contraceptives during the previous 6 months.
  • Participants must be pre-menopausal women.
  • Participants must have a high risk of developing breast cancer based on certain criteria. This should be discussed with the study doctor.
  • Participants must not have had a diagnosis of breast cancer within the past 5 years, and cannot currently have any other type of cancer.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participation will include a total of 4 clinic visits and 4 phone calls. Participants will be randomly assigned to receive active SDG or placebo for 12 months. The placebo contains the same filler materials as commercially available Brevailâ„¢, but without the active SDG. Participants will have twice the chance of being assigned to active SDG as of being assigned to placebo. Participants will take 1 capsule, orally, per day, during the treatment period. When finished taking the study agent, the final study visit includes a mammogram and a repeat random peri-aerolar fine needle aspiration.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 23-Aug-14 08:21 AM

 

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