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NCT03654638
Soy Bread Diet in Improving Immune Function in Participants With Prostate Cancer
Phase 2 trial testing Dietary Intervention in Prostate Adenocarcinoma in 25 participants. Completed in 9 March 2022.
9 March 2022
Quick facts
| Lead sponsor | Ohio State University Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 25 |
| Start date | 15 August 2018 |
| Primary completion | 9 March 2022 |
| Estimated completion | 9 March 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dietary Intervention
- Dietary Intervention
- Questionnaire Administration
Conditions studied
- Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →
Sponsor
Ohio State University Comprehensive Cancer Center
Who can join
18 and older, male only, with Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Myeloid-derived suppressor cells as immunosuppressive regulators and therapeutic targets in cancer.
Li K, Shi H, Zhang B, Ou X, et al · · 2021 · cited 687× · PMID 34620838 · DOI 10.1038/s41392-021-00670-9 -
Myeloid-Derived Suppressor Cells as Key Players and Promising Therapy Targets in Prostate Cancer.
Siemińska I, Baran J. · · 2022 · cited 24× · PMID 35860573 · DOI 10.3389/fonc.2022.862416 -
Sex-biased adaptive immune regulation in cancer development and therapy.
Schafer JM, Xiao T, Kwon H, Collier K, et al · · 2022 · cited 22× · PMID 35880048 · DOI 10.1016/j.isci.2022.104717
Verify or expand the search:
- PubMed search for NCT03654638
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dietary Intervention
Trials testing the same drug.
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- NCT07091864 — Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma · NA · recruiting
- NCT06954584 — Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovari · Phase 3 · recruiting
- NCT06900439 — Exploring Glycemic Responses Through Continuous Monitoring in a Healthy Population · NA · completed
- NCT06336902 — Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorec · Phase 1 · recruiting
Other recruiting trials for Prostate Adenocarcinoma
Currently open trials in the same condition.
- NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
- NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
- NCT06957691 — Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Pro · Phase 2 · recruiting
- NCT07025369 — Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With H · Phase 2 · recruiting
- NCT06967961 — Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers · NA · recruiting
Other Ohio State University Comprehensive Cancer Center trials
Trials by the same sponsor.
- NCT06816979 — Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell · NA · not yet recruiting
- NCT07529483 — Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cysts · Phase 2 · not yet recruiting
- NCT07455513 — A Novel Tobacco Cessation Resource for Smokers With a Diagnosed or Suspected Thoracic Cancer · NA · not yet recruiting
- NCT07217990 — Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer · Phase 1, PHASE2 · not yet recruiting
- NCT07503925 — THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health · Phase 4 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03654638 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center
- Last refreshed: 4 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03654638.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing