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Isoflavones
Soy Isoflavones for Prostate Cancer
N/A
Waitlist Available
Led By Yael Vodovotz
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose
Awards & highlights
Study Summary
This trial is studying whether soy isoflavones can prevent cancer recurrence in patients with prostate cancer.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites
Secondary outcome measures
Change in hormonal patterns after soy bread and soy-almond bread interventions
Changes in hormonal patterns that favor anti-prostate cancer activity
Severity of toxicity in participants after consumption of the control soy bread or beta-glucosidase-enriched soy almond bread
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Soy -Almond Bread InterventionExperimental Treatment1 Intervention
Arm II Soy-Almond Bread
Group II: Soy Bread InterventionActive Control1 Intervention
Arm I Soy Bread
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arm II Soy-Almond Bread
2009
N/A
~40
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,135 Total Patients Enrolled
10 Trials studying Prostate Cancer
2,170 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,515 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Yael VodovotzPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot take over-the-counter drugs to improve urinary tract symptoms.You have used antibiotics within the past 6 months.You have cancer, other than prostate cancer, that requires active treatment.You have an allergy to tree nuts, soy, or wheat protein.You cannot take medication for urinary problems that block the flow of urine.People with diabetes are allowed to take part in the study.You have a history of pituitary gland hormone diseases that require taking additional hormones, except for diabetes, osteoporosis, and thyroid hormone replacement therapy that has been stable for at least six months.You are not planning to receive any other treatments for prostate cancer in the next 5 months.
Research Study Groups:
This trial has the following groups:- Group 1: Soy Bread Intervention
- Group 2: Soy -Almond Bread Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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