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Soy Isoflavones for Breast Cancer Risk Reduction
Phase 2
Waitlist Available
Led By Lee-Jane W Lu, Ph.D.
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one or two years after dietary supplement
Awards & highlights
Study Summary
This trial will investigate the effect of soy isoflavones on breast density and bone mineral density in postmenopausal women.
Who is the study for?
This trial is for healthy premenopausal women aged 30 to 42 with normal mammograms and regular menstrual cycles. It's not for those on special diets, abnormal mammograms, hormone treatments, pregnant or breastfeeding, with breast surgery history, soy allergies, or family breast cancer.Check my eligibility
What is being tested?
The study examines if consuming soy isoflavones can reduce the risk of developing breast cancer by potentially lowering breast and bone density due to their weak estrogen-like effects compared to a carbohydrate control.See study design
What are the potential side effects?
Soy isoflavones may cause mild digestive issues or allergic reactions in sensitive individuals. However, they are generally considered safe and side effects are typically minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one or two years after dietary supplements
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one or two years after dietary supplements
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breast density
Secondary outcome measures
bone density
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 1Experimental Treatment1 Intervention
soy isoflavones
Group II: 2Placebo Group1 Intervention
carbohydrates (maltodextrin)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
isoflavones
2002
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
The University of Texas Medical Branch, GalvestonLead Sponsor
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56,401 Total Patients Enrolled
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581 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
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1,543,163 Patients Enrolled for Breast Cancer
National Center for Research Resources (NCRR)NIH
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316,819 Total Patients Enrolled
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804 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to soy products.Your close family members have had breast cancer.You are currently following a specific diet recommended by a doctor.Your mammogram results are not normal.You are around the age of menopause or have already gone through menopause.You are between 30 and 42 years old.You have had surgery to change the size or shape of your breasts.Women who are not yet going through menopause and are healthyYou have normal results from mammograms.You have regular periods.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If a patient is under 45 years old, can they participate in this experiment?
"The age range that is eligible for this trial starts at 30 years old and goes up to 42."
Answered by AI
If I join this research program, will my insurance cover the costs?
"This clinical study is enrolling around 197 patients that have breast cancer and are aged between 30 and 42."
Answered by AI
What are the official guidelines from the FDA regarding isoflavones?
"isoflavones, which are being trialed in Phase 2 clinical trials, have some safety data backing their use but no evidence of efficacy yet."
Answered by AI
Are there any vacancies in this trial for potential participants?
"This particular study, which was first made public on April 1st, 2004 is not actively recruiting patients according to the latest update from clinicaltrials.gov on November 8th, 2021. Although this research project isn't looking for participants at the moment, there are 2698 other trials that are currently enrolling patients."
Answered by AI
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