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

Primary Purpose

Prostate Adenocarcinoma

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Dietary Intervention
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I Soy Bread Intervention

Arm II Wheat Bread Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
Treatment effects in prostate specific antigen (PSA)
Mixed-effects regression models will be used to estimate the treatment effect.

Secondary Outcome Measures

PSA response
Mixed-effects models will be used to explore treatment effects in PSA outcomes

Full Information

First Posted
August 29, 2018
Last Updated
December 9, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03654638
Brief Title
Soy Bread Diet in Improving Immune Function in Participants With Prostate Cancer
Official Title
The Effect of a Soy Bread Diet Intervention on Immune Function in Men With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
March 9, 2022 (Actual)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I Soy Bread Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II Wheat Bread Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
The dietary intervention requires men to consume 2 slices soy bread each day for 20 weeks while initiating hormone therapy
Intervention Type
Combination Product
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
The dietary intervention requires men to consume 2 slices wheat bread each day for 20 weeks while initiating hormone therapy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in peripheral blood myeloid derived suppressor cells (MDSC)
Description
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
Title
Treatment effect on peripheral blood MDSC
Description
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
Title
Treatment effects in plasma cytokines
Description
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
Title
Treatment effects in T-cell proliferation
Description
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
Title
Treatment effects in prostate specific antigen (PSA)
Description
Mixed-effects regression models will be used to estimate the treatment effect.
Time Frame
Up to week 20
Secondary Outcome Measure Information:
Title
PSA response
Description
Mixed-effects models will be used to explore treatment effects in PSA outcomes
Time Frame
Up to week 20

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Clinton, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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