CompletedNot Applicable

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

Canada99 participantsStarted 2015-09

Plain-language summary

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).

Who can participate

Age range

57 Years – 64 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.

Exclusion criteria

. Consumers of flaxseed and soy (including supplements) in the past 6 months.
. Consumers of sesame oil and sesame seeds in the past 6 months.
. Women who took antibiotics orally in the past 6 months.
. Women who took hormone replacement therapy or corticosteroids in the past month.
. Non-English speaking.
. Current chronic illnesses such as bowel disease (e.g. IBS - irritable bowel syndrome, or IBD - inflammatory bowel disease, such as Crohn's or ulcerative colitis), diabetes, heart disease (e.g. high cholesterol or high blood pressure and on medication for it), cancer, or another chronic illness.
. Women who are currently taking blood thinners, such as Warfarin.

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

Change in circulating levels of sex steroid hormones at Day 0 (baseline) compared with ~Day 50 (end of study period)

Timeframe: Day 0 and ~Day 50

Trial details

NCT IDNCT02501031

SponsorCancer Care Ontario

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06

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