The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors
Public ClinicalTrials.gov record NCT05967533. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Single Arm Study to Assess the Immune Effects of Fermented Wheat Germ (FWG) Nutritional Supplementation in Patients With Advanced Malignancies Being Treated With Standard of Care Checkpoint Inhibitor-Based Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I clinical trial tests the immune effects of fermented wheat germ in patients with advanced solid tumor cancers who are being treated with standard of care checkpoint inhibitors. Fermented wheat germ is a nutritional supplement that some claim is a "dietary food for special medical purposes for cancer patients" to support them in treatment. There have also been claims that fermented wheat germ is "clinically proven" and "recognized by medical experts" to "enhance oncological treatment" and boost immune response to cancer; however, there are currently no documented therapeutic effects of fermented wheat germ as a nutritional supplement. Checkpoint inhibitors, given as part of standard of care for advanced solid tumors, are a type of immunotherapy that may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. The information gained from this trial may allow researchers to determine if there is any value of giving fermented wheat germ with standard of care checkpoint inhibitors for patients with advanced solid tumor malignancies.
Study identification
- NCT ID
- NCT05967533
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 100 participants
Conditions and interventions
Conditions
- Advanced Colorectal Carcinoma
- Advanced Lung Non-Small Cell Carcinoma
- Advanced Malignant Solid Neoplasm
- Advanced Melanoma
- Advanced Renal Cell Carcinoma
- Advanced Triple-Negative Breast Carcinoma
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer (AJCC) v8
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Stage III Colorectal Cancer AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage III Renal Cell Cancer AJCC v8
- Stage IV Colorectal Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IV Renal Cell Cancer AJCC v8
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 1, 2023
- Primary completion
- May 31, 2027
- Completion
- Nov 30, 2027
- Last update posted
- Jun 30, 2026
2023 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05967533, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05967533 live on ClinicalTrials.gov.