A Phase 2 interventional study of Dietary Intervention and Dietary Intervention in Prostate Adenocarcinoma, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Ohio State University Comprehensive Cancer Center · Phase 2, Interventional, and Other
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.
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.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 25 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Combination Product: Dietary Intervention · Other: Questionnaire Administration
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.
Combination Product: Dietary Intervention · Other: Questionnaire Administration
The dietary intervention requires men to consume 2 slices soy bread each day for 20 weeks while initiating hormone therapy
Also known as: Dietary Modification, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
The dietary intervention requires men to consume 2 slices wheat bread each day for 20 weeks while initiating hormone therapy
Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Ancillary studies
Change in peripheral blood myeloid derived suppressor cells (MDSC)
A two-sample t-test will be used to compare the differences (log-transformed if necessary to improve normality).
Time frame: Week 0 to week 20
Treatment effect on peripheral blood MDSC
Mixed-effects regression models will be used to estimate the treatment effect on peripheral blood MDSC after adjusting for covariates such as age, compliance, and weight. A condition by time (pre versus \[vs.\] post) interaction will be included to test for a treatment effect. A random effect will be included for each subject to account for the dependency between the pre-post measurements. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 5 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used. Tissue MDSC will be compared using linear regression.
Time frame: Up to week 20
Treatment effects in plasma cytokines
Mixed-effects regression models will be used to estimate the treatment effect. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 5 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used.
Time frame: Up to week 20
Treatment effects in T-cell proliferation
Mixed-effects regression models will be used to estimate the treatment effect. Correlations (Pearson and Spearman) between measures will be evaluated to determine if positive or negative relationships exist between the measures themselves or the week 0 to week 20 differences (e.g. MSDC vs. T-cell proliferation, MDSC vs. cytokines). Model adequacy and assumptions will be evaluated via residual plots. In the event that model assumptions are violated, outcomes will be transformed or non-parametric methods will be used.
Time frame: Up to week 20
Treatment effects in prostate specific antigen (PSA)
Mixed-effects regression models will be used to estimate the treatment effect.
Time frame: Up to week 20
PSA response
Mixed-effects models will be used to explore treatment effects in PSA outcomes
Time frame: Up to week 20
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center