CompletedPhase 1

Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women

36 participantsStarted 2004-03

Plain-language summary

The purpose of this research study is to examine the safety of specific soy components, known as isoflavones, and to find out what effects (good and bad) these components have on tissues that are sensitive to the hormone estrogen in healthy, post-menopausal women. Isoflavones are compounds that occur naturally in soybeans and can be extracted to put in to capsule form or add to foods. The capsule formulation being used in this study is considered an investigational drug. This research is being done because many scientists believe that isoflavones may play a role in the prevention of some kinds of cancer. While isoflavones have been safely consumed in foods for centuries, we need to know if these soy components are safe to take in higher doses when they are extracted from foods and provided in a supplement form. We plan to test the safety and effects of the soy isoflavones known as genistein, daidzein and glycitein.

Who can participate

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.

Inclusion Criteria: * Performance status 0, 1, or 2 on ECOG scale * Acceptable hematopoietic, hepatic, and renal function (WBC≥3500 µL, platelet count ≥ 100,000/ml, serum creatinine \< 2.0 mg/dl, serum bilirubin ≤ 2.0 mg/dl, transaminases \< two times normal limits) * Post-menopausal status - FSH level \> 27 mIU/ml, no spontaneous bleeding \> 1 year * Normal mammogram within the last 13 months * Normal Papanicolaou Test within the last 13 months Exclusion Criteria: * Serious intercurrent medical illnesses or history of seizure * Significant cardiac disease (New York Heart Association Class III or IV) * Abnormalities on the physical examination screen including significant abnormality of the heart, lungs, liver, spleen, or other abdominal organs, or neurologic abnormality Abnormalities on the biochemical screen that could be metabolically significant * Individuals with intermediate equol values (\> 10 ug/L to \< 20 ug/L) on soy challenge * Use of antibiotics within the last 3 months * Use of hormone/estrogen therapy or SERMs within the last 3 months * Abnormal thyroid or endocrine function tests; or current use of thyroid medication * BMI at or above 35 * History of complete hysterectomy or oophorectomy * High risk of breast cancer (5-year risk of \>1.9%) based on NCI's Breast Cancer Risk Assessment Tool * A history of a malignancy active or initially diagnosed within 2 years other than curatively treated non-melanoma carcinoma of the skin * History of substance abuse or ad…

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

DNA damage, apoptosis, estrogenic effects and changes in gene expression

Timeframe: 112 days

Trial details

NCT IDNCT00491595

SponsorUniversity of North Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Drug Toxicity trials

Plain-language summary

Who can participate

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.