Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer
|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 ]
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|