Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00794989|
Recruitment Status : Terminated (low accrual)
First Posted : November 21, 2008
Last Update Posted : June 3, 2016
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 or disease||Intervention/treatment||Phase|
|Breast Cancer Precancerous Condition||Dietary Supplement: Ground Flaxseed Other: No Intervention||Not Applicable|
Determine if 25 grams of flaxseed supplementation daily
- modifies proliferation (ki-67) and apoptotic rates after six months
- modifies expression of estrogen regulated genes: Cyclin D1, survivin, and VEGF at six months
- modifies serum IGF-1 and serum binding protein (IGFBP)-3 levels from baseline to 6 months
- and evaluate the feasibility and tolerability of flaxseed consumption, and determine factors that lead to decreased compliance
This is a randomized study. Patients are randomized to 1 of 2 arms.
- Arm I (intervention): Patients ingest 25 grams ground flaxseed daily, with already prepared foods, for 6 months. Patients are instructed to record the time and with what foods flaxseed is consumed, and the number of bowel movements daily. Throughout the 6-month intervention period, patients also complete unannounced telephone-administered surveys recounting all foods and beverages consumed within the previous 24 hours.
- Arm II (observation): Patients do not receive ground flaxseed. All patients complete a diary about menstrual cycle duration and presence or improvement of premenstrual symptoms (e.g., cramping, bloating, headache, insomnia, or other irregular symptoms). Patients also complete questionnaires at 1, 3, and 6 months to access changes in diet, physical activity, menstrual history, demographic characteristics, and medical history and a specimen questionnaire at baseline and at 1, 3, and 6 months.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Arm 1: Intervention
Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.
Dietary Supplement: Ground Flaxseed
Arm 2: Observational
Patients do not receive ground flaxseed.
Other: No Intervention
Participants randomized to Arm 2 do not receive any intervention
- Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months [ Time Frame: 6 months ]
- Tolerability and compliance [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794989
|United States, Illinois|
|University of Chicago Medicine|
|Chicago, Illinois, United States, 60637|
|United States, New York|
|Roswell Cancer Park Institute|
|Buffalo, New York, United States, 14263|
|Principal Investigator:||Swati Kulkarni, M.D.||University of Chicago|