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

Breast Cancer Clinical Trial

Official title: A Study Evaluating the Effect of Flaxseed on Biomarkers of Breast Cancer Risk

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Precancerous Condition
• Precancerous Conditions

• NCT number: NCT00794989
• Study type: Interventional
• Source: Roswell Park Cancer Institute
• Status: Terminated
• Phase: N/A
• Start date: April 2008
• Completion date: June 2011