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

Not Applicable

Terminated

• Conditions: Breast Cancer; Precancerous Condition
• Interventions: Other: No Intervention; Dietary Supplement: Ground Flaxseed

• Registration Number: NCT00794989
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary aims:

* 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

STUDY OUTLINE:

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Observational	No Intervention	Patients do not receive ground flaxseed.
Arm 1: Intervention	Ground Flaxseed	Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.

Primary Outcome Measures

Name	Time	Method
Alteration in intermediate biomarkers of breast cancer risk at baseline and at 1, 3, and 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Tolerability and compliance	6 months

Trial Locations

Locations (2)

Roswell Cancer Park Institute; 🇺🇸 Buffalo, New York, United States

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States