NCT00794989

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Precancerous Condition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ground Flaxseed	Given orally
OTHER	No Intervention	Participants randomized to Arm 2 do not receive any intervention

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-11-21
• Last updated: 2016-06-03

Locations

2 sites across 1 country: United States