Soy Bread Diet in Improving Immune Function in Participants With Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title: The Effect of a Soy Bread Diet Intervention on Immune Function in Men With Prostate Cancer

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To precisely define the impact of soy on myeloid derived suppressor cells (MDSC) in a human model clinical trial.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (SOY BREAD): Participants consume 2 slices of soy bread daily for approximately 20 weeks in the absence of unacceptable toxicity. Concurrent with the intervention, participants will be staring androgen deprivation therapy at the direction of their medical oncologist.

ARM II (WHEAT BREAD): Participants consume 2 slices of wheat bread daily for approximately 20 weeks in the absence of unacceptable toxicity. Concurrent with the intervention, participants will be staring androgen deprivation therapy at the direction of their medical oncologist. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma

• NCT number: NCT03654638
• Study type: Interventional
• Source: Ohio State University Comprehensive Cancer Center
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 15, 2018
• Completion date: March 1, 2025