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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03654638
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Combination Product: Dietary Intervention Other: Questionnaire Administration Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of a Soy Bread Diet Intervention on Immune Function in Men With Prostate Cancer
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm I Soy Bread Intervention
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
The dietary intervention requires men to consume 2 slices soy bread each day for 20 weeks while initiating hormone therapy
Other Names:
  • Dietary Modification
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II Wheat Bread Intervention
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
The dietary intervention requires men to consume 2 slices wheat bread each day for 20 weeks while initiating hormone therapy
Other Names:
  • Dietary Modification
  • intervention, dietary
  • Nutrition Intervention
  • Nutrition Interventions
  • Nutritional Interventions

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in peripheral blood myeloid derived suppressor cells (MDSC) [ Time Frame: Week 0 to week 20 ]
    A two-sample t-test will be used to compare the differences (log-transformed if necessary to improve normality).

  2. Treatment effect on peripheral blood MDSC [ Time Frame: Up to week 20 ]
    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.

  3. Treatment effects in plasma cytokines [ Time Frame: Up to week 20 ]
    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.

  4. Treatment effects in T-cell proliferation [ Time Frame: Up to week 20 ]
    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.

  5. Treatment effects in prostate specific antigen (PSA) [ Time Frame: Up to week 20 ]
    Mixed-effects regression models will be used to estimate the treatment effect.


Secondary Outcome Measures :
  1. PSA response [ Time Frame: Up to week 20 ]
    Mixed-effects models will be used to explore treatment effects in PSA outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654638


Contacts
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Contact: The Ohio State University Comprehensive Cancer Center 1-800293-5066 OSUCCCClinicaltrials@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Steven Clinton, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steven Clinton, MD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03654638    
Other Study ID Numbers: OSU-12042
NCI-2018-00808 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2012C0045
OSU-12042 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
P30CA016058 ( U.S. NIH Grant/Contract )
R01CA169363 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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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
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type