Wheat germ supplement studied for immune boost in advanced cancer
NCT ID NCT05967533
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study looks at whether a fermented wheat germ supplement can help the immune system fight cancer better when taken with standard immunotherapy drugs. About 100 adults with advanced solid tumors (like lung, colon, or melanoma) will take the supplement alongside their usual treatment. The main goal is to measure changes in natural killer cell activity, not to cure the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically or cytologically confirmed non small cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), melanoma, colorectal carcinoma (CRC) and triple-negative breast cancer (TNBC) solid tumor malignancies deemed appropriate to receive standard-of-care checkpoint inhibitor (CPi)-based therapy * Age \>= 18 years of age at time of consent * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Life expectancy of greater than 6 months * Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation (including dosing interruptions) and for 5 months (150 days) after the last dose of study agent. Women must agree to refrain from egg donation during this timeframe * Male subjects must agree to employ an effective method of birth control starting dose from cycle 1 day 1, including dosing interruptions through 90 days after receipt of the last dose of fermented wheat germ (FWG). Male subjects must agree to refrain from sperm donation while taking FWG during study treatment for at least 90 days after the last dose of FWG * Ability to understand and the willingness to sign a written informed consent document * Must be able to swallow study treatment Exclusion Criteria: * Prior allogeneic bone marrow transplantation or solid organ transplantation * Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to cycle 1 day 1. However, the following therapies are allowed: \* Hormone-replacement therapy or oral contraceptives \* Herbal therapy intended as anticancer therapy must be discontinued for at least 1 week prior to enrollment) * Any subject who have not recovered to at least grade 2 from adverse events (other than alopecia) due to agents administered more than 2 weeks earlier. Treatment with any other investigational agent within 3 weeks * Currently taking FWG * Treatment with systemic immunostimulatory agents (for example, interferon \[IFN\]-alpha or interleukin \[IL\]-2) within 6 weeks prior * Current or prior use of immunosuppressive medications (for example, corticosteroid, cyclophosphamide, azathioprine, methotrexate, thalidomide, calcineurin inhibitors, and anti-tumor necrosis factor \[anti-TNF\] agents) within 14 days prior to first dose of FWG. The following are exceptions to this criterion: \* Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10 mg/day of prednisone or equivalent may be enrolled \* Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled \* The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed * Patients taking bisphosphonate therapy for hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed * Known history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to the study agent (e.g., gluten) * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis, Crohn's disease\], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \[granulomatosis with polyangiitis\]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis; uveitis; etc.) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment * History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan.History of radiation pneumonitis in the radiation field (fibrosis) is permitted \* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible \* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible * Patients with known active tuberculosis * Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of need for a major surgical procedure during the study * Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or anticipation that such a live, attenuated vaccine will be required during the study and up to 5 months after the last dose of FWG * Must not have received live, attenuated influenza vaccine within 4 weeks prior to cycle 1, day 1 or at any time during the study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would interfere with patient safety or limit compliance with study requirements * Female subjects who are pregnant or breast-feeding * Any condition that would prohibit the understanding or rendering of informed consent in the opinion of the investigator * Prior intolerance to checkpoint inhibitor (CPi)-based therapies * Any medical condition that in the opinion of the investigator would interfere with the patient's safety or compliance while on trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
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Other studies related to the condition(s) this trial covers.
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