TerminatedNot Applicable

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

Stopped: low accrual

United States20 participantsStarted 2008-04

Plain-language 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.

Who can participate

Age range

21 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Patients enrolled in must meet ≥ 1 of the following criteria: * History of unilateral or bilateral atypical ductal hyperplasia with or without family history * History of atypical lobular hyperplasia or lobular carcinoma in situ with or without family history * History of ductal carcinoma in situ * Prior stage I breast cancer allowed provided it was adequately treated and therapy was completed ≥ 1 year ago * Lifetime risk for developing breast cancer \> 20% (based on Gail or Claus model) * No abnormal mammogram requiring short-term follow-up within the past 6 months * No severe atypia or carcinoma cells on RPRNA PATIENT CHARACTERISTICS: * Premenopausal * ECOG performance status 0-1 * Patients enrolled must meet the following criteria: * No peri- or postmenopausal status as determined by estradiol levels \< 20 ng/dL and FSH levels \> 45 ng/dL * No thrombocytopenia (defined as platelet count \< 50,000/mm\^3) * Creatinine ≤ 1.5 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception consistently * No other prior malignancy allowed except for the following: * Basal cell or squamous cell carcinoma * In situ cervical cancer * No history of any of the following conditions within the past 5 years: * Crohn disease * Ulcerative colitis * Inflammatory bowel disease * Irritable bowel syndrome * Celiac sprue * Malabsorption syndrome * Diverticulitis * Diverticulosis * No allergy to fl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT00794989

SponsorRoswell Park Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

View on ClinicalTrials.gov More Breast Cancer trials