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

NCT03654638 | Completed Phase 2 DMC

• 3 other identifiers: OSU-12042NCI-2018-00808R01CA169363
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (1)

• PSA response

  Up to week 20

Study Arms (2)

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.

Combination Product: Dietary Intervention; Other: Questionnaire Administration

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.

Combination Product: Dietary Intervention; Other: Questionnaire Administration

Interventions

Dietary Intervention COMBINATION_PRODUCT

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

Arm I Soy Bread Intervention

Questionnaire Administration OTHER

Ancillary studies

Arm I Soy Bread Intervention; Arm II Wheat Bread Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have biopsy proven adenocarcinoma of the prostate (no small cell, sarcomatoid, or other rare subtypes)
• Be planning a course of at least 5 months of androgen deprivation therapy. Patients who have had androgen deprivation therapy in the past as part of salvage therapy or primary therapy, but are initiating a new course will be eligible.
• Have a testosterone concentration within normal limits.
• No neoadjuvant hormonal or chemotherapy (other clinical trials) for their prostate cancer
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Have blood, urea, nitrogen (BUN)/creatinine (Cr), liver enzymes, complete blood count (CBC), and prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) within normal limits
• Voluntarily agree to participate and a sign an informed consent document
• Agree to have prostate biopsy blocks provided to the study for evaluation
• Willing to discontinue all current vitamin/mineral supplements
• Not currently be taking complementary or alternative products (i.e. PC-SPES, Saw Palmetto) that target the prostate or may impact the hormonal environment
• Agree to consume a standardized vitamin and mineral supplement (provided by the study) and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study

You may not qualify if:

• Have an active malignancy other than prostate cancer that requires therapy
• No diagnosed hematologic malignancy
• Not currently taking steroid medications (i.e., chronic lymphocytic leukemia \[CLL\])
• No chronic infection (i.e., human immunodeficiency virus-positive \[HIV+\])
• No history of organ transplant requiring immunosuppressive medications
• History of nephrolithiasis (renal stones)
• Renal insufficiency with creatinine \> 1.8, including anyone on dialysis regardless of nadir creatinine
• Have certain medical conditions. Have no history of malabsorptive disorders or other metabolic disorders requiring special diet recommendations (for example, Crohn?s disease or gluten enteropathy)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Steven Clinton, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: August 15, 2018
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

US (1)