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Soy Bread Diet for Prostate Cancer
Phase 2
Waitlist Available
Led By Steven Clinton, MD
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
Have biopsy proven adenocarcinoma of the prostate (no small cell, sarcomatoid, or other rare subtypes)
Agree to consume a standardized vitamin and mineral supplement (provided by the study) and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 20
Awards & highlights
Study Summary
This trial studies the effects of a soy bread versus a wheat bread in improving immune function in participants with prostate cancer.
Who is the study for?
Men with prostate cancer starting androgen deprivation therapy can join this trial. They must have normal organ function tests, agree to stop taking vitamins/minerals except those provided by the study, not be on steroids or other prostate-targeting supplements, and have no history of certain medical conditions like Crohn's disease.Check my eligibility
What is being tested?
The trial is testing if eating soy bread can boost immune function in men undergoing hormone therapy for prostate cancer compared to wheat bread. Participants will eat the assigned bread type while their immune response is monitored.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort or allergic reactions specific to soy or wheat products.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowSelect...
I have a confirmed diagnosis of common prostate cancer.
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I agree to only take the study's vitamins and avoid other supplements.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am willing to stop taking all my current vitamins and minerals.
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I am not using any alternative products for prostate health.
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I am starting a new course of hormone therapy for at least 5 months.
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I haven't had hormone or chemotherapy for my prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 20
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 20
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in peripheral blood myeloid derived suppressor cells (MDSC)
Treatment effect on peripheral blood MDSC
Treatment effects in T-cell proliferation
+2 moreSecondary outcome measures
PSA response
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I Soy Bread InterventionExperimental Treatment2 Interventions
Men who are scheduled to begin androgen deprivation therapy for prostate cancer will begin an intervention to consume 2 slices of soy bread daily for approximately 20 weeks. Blood, urine and toxicity data will be collected at regularly scheduled medical oncology visits.
Group II: Arm II Wheat Bread InterventionActive Control2 Interventions
Men who are scheduled to begin androgen deprivation therapy for prostate cancer will begin an intervention to consume 2 slices of wheat bread for approximately 20 weeks. Blood, urine and toxicity data will be collected at regularly scheduled medical oncology visits.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention
2014
Completed Phase 2
~2550
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
316 Previous Clinical Trials
289,661 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,621 Total Patients Enrolled
Steven Clinton, MD5.05 ReviewsPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
6 Previous Clinical Trials
1,811 Total Patients Enrolled
5Patient Review
Dr. Clinton is amazing. Not only is he dedicated to his research, but he also takes the time to get to know each of his patients as individuals. He truly cares about his patients and their well-being. I've been seeing him for years and he has always been attentive and responsive to my concerns. I would highly recommend him to anyone seeking treatment for prostate cancer.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had kidney stones in the past.I have not been diagnosed with blood cancer.I have a confirmed diagnosis of common prostate cancer.I agree to only take the study's vitamins and avoid other supplements.I am fully active or restricted in physically strenuous activity but can do light work.I am willing to stop taking all my current vitamins and minerals.I am not using any alternative products for prostate health.My kidney function is low, with creatinine over 1.8 or I am on dialysis.I don't have diseases like Crohn's that affect how my body absorbs food.I am being treated for a cancer other than prostate cancer.I do not have a chronic infection like HIV.I have never had an organ transplant that needed drugs to suppress my immune system.I am not currently on steroid medications.I am starting a new course of hormone therapy for at least 5 months.I haven't had hormone or chemotherapy for my prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II Wheat Bread Intervention
- Group 2: Arm I Soy 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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