Soy Bread Diet for Prostate Cancer

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Ohio State University Comprehensive Cancer Center

Must be taking: Androgen deprivation

Must not be taking: Steroids, Complementary products

Disqualifiers: Active malignancy, Hematologic malignancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effects of a soy bread versus a wheat bread in improving immune function in participants who are beginning a course of androgen deprivation therapy for prostate cancer. Components found in soy foods may influence the immune system in a way that may be beneficial for prostate cancer prevention and survivorship.

Research Team

Steven Clinton, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion Criteria

I have had kidney stones in the past.

I have not been diagnosed with blood cancer.

My kidney function is low, with creatinine over 1.8 or I am on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume 2 slices of soy or wheat bread daily for approximately 20 weeks while undergoing androgen deprivation therapy

20 weeks

Regularly scheduled medical oncology visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Soy Bread

Trial Overview 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.

Participant Groups

Group I: Arm I Soy Bread Intervention Experimental Treatment 2 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 Intervention Active Control 2 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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+