Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women (NCT00513916) | Clinical Trial Compass
CompletedPhase 3
Effect of Dietary Soy on Estrogens in Breast Fluid, Blood, and Urine Samples From Healthy Women
United States100 participantsStarted 2006-07
Plain-language summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a diet high in isoflavones, compounds found in soy foods, may keep cancer from forming.
PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women.
Who can participate
Age range
30 Years – 45 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.
DISEASE CHARACTERISTICS:
* Healthy participant
* No diagnosis of cancer
PATIENT CHARACTERISTICS:
* Premenopausal
* Regular menstrual cycles
PRIOR CONCURRENT THERAPY:
* Not taking birth control pills or other hormones
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
1
Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum
2
Cytologic patterns of epithelial breast cells obtained from NAF
3
Effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen metabolites
4
Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase
Trial details
NCT IDNCT00513916
SponsorUniversity of Hawaii Cancer Research Center