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NCT05967533 · ClinicalTrials.gov registry record · Phase 1
The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors
A Phase 1 study of Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, sponsored by University of California, Davis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05967533 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8 that is actively recruiting participants, run by University of California, Davis. The registered enrollment target is 100 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05967533, a Phase 1 study of Advanced Malignant Solid Neoplasm and Anatomic Stage III Breast Cancer AJCC v8, is actively recruiting participants, sponsored by University of California, Davis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Fermented Wheat Germ Extract
Study Locations (1)
California
- University of California Davis Comprehensive Cancer Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05967533
The ClinicalTrials.gov registry entry for NCT05967533 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (43% lower). The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Fermented Wheat Germ Extract is the first listed.
NCT05967533 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05967533 about?
NCT05967533 is a clinical study titled "The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors". 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 purpos...
What is the current status of trial NCT05967533?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2023-06-02. Estimated completion is 2026-12.
What conditions does trial NCT05967533 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT05967533?
The interventions under investigation include: Fermented Wheat Germ Extract (DRUG).
Who is sponsoring clinical trial NCT05967533?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05967533 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.