NCT03654638

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Dietary Intervention	The dietary intervention requires men to consume 2 slices soy bread each day for 20 weeks while initiating hormone therapy
COMBINATION_PRODUCT	Dietary Intervention	The dietary intervention requires men to consume 2 slices wheat bread each day for 20 weeks while initiating hormone therapy
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-08-15
• Primary completion: 2022-03-09
• Completion: 2022-03-09
• First posted: 2018-08-31
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States