NCT05967533

The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess the effect of fermented wheat germ (FWG) nutritional supplementation on natural killer (NK) cell killing activity in peripheral blood of cancer patients being treated with standard of care (SOC) immunotherapy who have voluntarily decided to take the FWG nutritional supplement. SECONDARY OBJECTIVES: I. To assess immunologic effects of FWG in subjects with cancer treated with checkpoint inhibitor (CPi)-based therapy. II. To archive stool specimens of subjects with cancer treated with CPi-based therapy for future non-interventional studies for subsequent analysis at completion of study. III. To evaluate toxicities of FWG in subjects with cancer treated with checkpoint inhibitor (CPi)-based therapy. IV. To assess immunologic effects of FWG in patients with cancer treated with CPi immune-oncology-based therapy (Immune Correlates).

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

Interventions

Type	Name	Description
DRUG	Fermented Wheat Germ Extract	Given orally (PO)

Timeline

• Start date: 2023-06-02
• Primary completion: 2026-06-02
• Completion: 2026-12-01
• First posted: 2023-08-01
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study