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

NCT03654638 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Prostate Adenocarcinoma

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ohio State University Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Steven Clinton, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2022-03-09
Completion
2022-03-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654638 on ClinicalTrials.gov