The Effect of a Soy Bread Diet Intervention on Immune Function in Men With Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in peripheral blood myeloid derived suppressor cells (MDSC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Dietary Intervention (Combination Product)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Dietary Intervention (Combination Product)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in peripheral blood myeloid derived suppressor cells (MDSC)
时间窗: Week 0 to week 20
A two-sample t-test will be used to compare the differences (log-transformed if necessary to improve normality).
Treatment effects in prostate specific antigen (PSA)
时间窗: Up to week 20
Mixed-effects regression models will be used to estimate the treatment effect.
Treatment effects in T-cell proliferation
时间窗: 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.
Treatment effect on peripheral blood MDSC
时间窗: 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.
Treatment effects in plasma cytokines
时间窗: 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.
次要结局
- PSA response(Up to week 20)
研究者
Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center