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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00808 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01CA169363 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I Soy Bread Intervention | Experimental | 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. |
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| Arm II Wheat Bread Intervention | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Combination Product | The dietary intervention requires men to consume 2 slices soy bread each day for 20 weeks while initiating hormone therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response | Mixed-effects models will be used to explore treatment effects in PSA outcomes | Up to week 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Clinton, MD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Dietary Intervention | Combination Product | The dietary intervention requires men to consume 2 slices wheat bread each day for 20 weeks while initiating hormone therapy |
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| Questionnaire Administration | Other | Ancillary studies |
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| Up to week 20 |
| Treatment effects in prostate specific antigen (PSA) | Mixed-effects regression models will be used to estimate the treatment effect. | Up to week 20 |