Actively Recruiting
The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors
Led by University of California, Davis · Updated on 2025-04-24
100
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced solid tumor malignancies including non-small cell lung carcinoma, renal cell carcinoma, melanoma, colorectal carcinoma, and triple-negative breast cancer appropriate for checkpoint inhibitor therapy
- Age 18 years or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky score ≥ 60%)
- Life expectancy greater than 6 months
- Women of child-bearing potential must agree to use effective contraception during and for 5 months after the study and refrain from egg donation
- Male subjects must agree to use effective birth control from treatment start through 90 days after last dose and avoid sperm donation during this time
- Ability to understand and sign informed consent
- Ability to swallow the study treatment
You will not qualify if you...
- Prior allogeneic bone marrow or solid organ transplantation
- Chemotherapy or radiotherapy within 2 weeks before treatment start (6 weeks for nitrosoureas or mitomycin C), except hormone therapy or oral contraceptives
- Not recovered to at least grade 2 from previous treatment side effects (except alopecia)
- Treatment with other investigational agents within 3 weeks
- Currently taking fermented wheat germ
- Use of systemic immunostimulatory agents within 6 weeks prior
- Use of immunosuppressive medications within 14 days prior, with some exceptions
- Use of bisphosphonate therapy for hypercalcemia
- Known allergy to compounds similar to the study agent (e.g., gluten)
- Active or recent autoimmune or inflammatory disorders within 3 years, with some exceptions
- History of certain lung diseases or active pneumonitis
- Known active tuberculosis
- Major surgery within 28 days prior or planned during the study
- Use of live attenuated vaccines within 4 weeks before or during study
- Uncontrolled illnesses that may interfere with safety or compliance
- Pregnant or breastfeeding females
- Inability to understand or give informed consent
- Prior intolerance to checkpoint inhibitor therapies
- Any condition interfering with safety or compliance as judged by the investigator
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Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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