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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00794989 |
RATIONALE: Ground flaxseed may prevent breast cancer in premenopausal women at increased risk of developing primary breast cancer.
PURPOSE: This randomized clinical trial is studying how well flaxseed works in preventing breast cancer in premenopausal women at risk of breast cancer.
Condition | Intervention |
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Breast Cancer Precancerous/Nonmalignant Condition |
Drug: flaxseed Procedure: observation |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Official Title: | A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Intervention: Experimental
Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.
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Drug: flaxseed
Given orally
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Non-intervention: No Intervention
Patients do not receive ground flaxseed.
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Procedure: observation
None
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label study (part 1) followed by a randomized study (part 2).
Part 1:
Patients are randomized to 1 of 2 arms.
Blood and first-void urine samples are collected at baseline and at 1, 3, and 6 months to measure levels of lignan metabolites, flaxseed compliance, serum thiocyanate, malondialdehyde, and for biomarker studies by capillary gas chromatography-mass spectrometry, high-performance liquid chromatography, and ELISA.
After completion of study therapy, patients are followed monthly for up to 6 months.
Ages Eligible for Study: | 21 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients enrolled in part 1 must meet the following criteria:
No contralateral breast malignancy by mammogram, ultrasound, and MRI
Patients enrolled in part 2 must meet ≥ 1 of the following criteria:
PATIENT CHARACTERISTICS:
Patients enrolled in part 1 must meet the following criteria:
Patients enrolled in part 2 must meet the following criteria:
No other prior malignancy allowed except for the following:
No history of any of the following conditions:
PRIOR CONCURRENT THERAPY:
Patients enrolled in part 1 must meet the following criteria:
No prior breast implants or tram-flap reconstruction
Patients enrolled in part 2 must meet the following criteria:
More than 1 year since prior chemotherapy and adjuvant hormonal therapy for breast cancer
No chronic/concurrent medications that inhibit platelet function, including any of the following:
Anti-platelet agents
No concurrent ingestion of the following:
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263-0001 | |
Contact: Swati Kulkarni, MD 716-845-2918 |
Principal Investigator: | Swati Kulkarni, MD | Roswell Park Cancer Institute |
Responsible Party: | Roswell Park Cancer Institute ( Swati Kulkarni ) |
Study ID Numbers: | CDR0000617894, RPCI-I-81906 |
Study First Received: | November 20, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00794989 |
Health Authority: | Unspecified |
breast cancer atypical ductal breast hyperplasia lobular breast carcinoma in situ ductal breast carcinoma in situ breast cancer |
Carcinoma, Lobular Hyperplasia Skin Diseases Precancerous Conditions Carcinoma in Situ |
Breast Neoplasms Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site |