Clinical trial · Interventional
Soy Bread Diet in Improving Immune Function in Participants With Prostate Cancer
The Effect of a Soy Bread Diet Intervention on Immune Function in Men With Prostate Cancer
NCT03654638CI-TRIAL-00088176completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary Intervention | Combination Product | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I Soy Bread Intervention
- 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.
- interventionNames
- Combination Product: Dietary Intervention
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II Wheat Bread Intervention
- 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.
- interventionNames
- Combination Product: Dietary Intervention
- Other: Questionnaire Administration
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.