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Flax

Patients ingest ground flaxseed daily, with already prepared foods, for 6 months.

Ground Flaxseed

Participants randomized to Arm 2 do not receive any intervention

No Intervention

Swati Kulkarni, M.D.

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.

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.

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

Roswell Park Cancer Institute

Menopause

Hormones

2 tablespoons of ground flaxseed taken daily for approximately 50 days.

Ground flaxseed

Michelle Cotterchio, PhD

The purpose of this study is to understand whether consuming flaxseed for approximately 50 days may beneficially affect the level of certain hormones in the blood thought to be involved in the development of breast cancer. This study will address the first steps toward the development of possible breast cancer prevention strategies. Differences in hormone levels (from blood samples) will be compared between two groups of women - those in the group assigned to eating ground flaxseed daily and those in the control group (with no change in diet).

PRIMARY OBJECTIVES:

I. Evaluate whether a dietary flaxseed intervention among post-menopausal women influences circulating levels of sex steroid hormones and estrogen metabolites (including estradiol, estrone, 2-hydroxy(OH)-/16-OH-estrone ratio, SHBG, testosterone, 2-MeOH-E1\&-E2, 4-MeOH-E1\&-E2) thought to be involved in the development of breast cancer.

SECONDARY OBJECTIVES:

II. Assess a) the effect of flaxseed intake on serum enterolignan levels (lignan biomarker), b) the relationship between serum enterolignan and sex hormone levels.

III. Describe adherence to the flaxseed intervention.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM 1: Participants take 2 tablespoons of ground flaxseed daily for approximately 50 days.

ARM 2: Participants maintain their usual diet for approximately 50 days.

All participants will complete a questionnaire and have their blood drawn at the beginning of the study (Day 0) and at the end of the study period (approximately Day 50).

Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women

Effect of Dietary Flaxseed on Circulating Sex Hormone Levels Among Post-menopausal Women - an Intervention Trial to Explore Flaxseed Intake as a Possible Breast Cancer Prevention Strategy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer	NCT00794989	Breast Cancer Precancerous Co...	Ground Flaxseed No Intervention	21 Years - 50 Years	Roswell Park Cancer Institute
Flaxseed Intervention Study to Assess Sex Hormone Levels Among Post-Menopausal Women	NCT02501031	Healthy	Ground flaxseed	57 Years - 64 Years	Cancer Care Ontario
Flaxseed in Preventing Breast Cancer in Premenopausal Women at Risk of Developing Breast Cancer	NCT00794989	Breast Cancer Precancerous Co...	Ground Flaxseed No Intervention	21 Years - 50 Years	Roswell Park Cancer Institute

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