RecruitingPhase 1NCT05967533

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


Sponsor

University of California, Davis

Enrollment

100 participants

Start Date

Jun 2, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a fermented wheat germ nutritional supplement — taken alongside standard immunotherapy (checkpoint inhibitor drugs) — can boost the immune response and improve treatment outcomes in patients with advanced solid tumors, including lung, kidney, colorectal, melanoma, and triple-negative breast cancers. **You may be eligible if...** - You have confirmed non-small cell lung cancer, renal cell carcinoma, melanoma, colorectal cancer, or triple-negative breast cancer - Your cancer is considered appropriate for standard checkpoint inhibitor therapy - You are 18 or older with adequate overall health (ECOG 0–2) and life expectancy of more than 6 months **You may NOT be eligible if...** - Your cancer type is not one of those listed above - You have serious autoimmune conditions that make checkpoint inhibitor immunotherapy unsafe - You have severe organ dysfunction - You have known allergies to wheat or wheat-derived products - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFermented Wheat Germ Extract

Given orally (PO)


Locations(1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

View Full Details on ClinicalTrials.gov

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NCT05967533


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