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

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT05967533
Phase
PHASE1
Status
Recruiting
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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 Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fermented Wheat Germ Extract — DRUG
    Given orally (PO)

Study Details

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.

Key Dates

Start date
Jun 2, 2023
Status verified
Apr 2025
Primary completion
Jun 2, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Fermented wheat germ
    Patients receive fermented wheat germ orally (PO) daily starting 3 days prior to the start of standard of care checkpoint inhibitor therapy on days 1-56 for 8 weeks. Patients undergo blood sample collection during screening, on days 1, 4, 15, 43 and at the end of treatment visit. Patients undergo stool sample collection during screening, day 1, 4 and at the end of treatment visit.

Primary Outcome Measure

Natural killer (NK) cell killing activity [ Time Frame: From baseline to Day 4 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Joseph M. Tuscano
[email protected]
916-734-3772
Joseph M. Tuscano (PRINCIPAL_INVESTIGATOR)

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By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CA

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