Effects of fermented wheat germ on immune response in cancer patients

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

This study is testing if taking fermented wheat germ can boost the immune response in cancer patients with advanced tumors who are already receiving standard treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Davis (Academic / other)
• Drugs / interventions: Chemotherapy, radiation, methotrexate, cyclophosphamide, prednisone, immunotherapy
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT05967533 on ClinicalTrials.gov

What this trial studies

This phase I clinical trial investigates the immune effects of fermented wheat germ supplementation in patients with advanced solid tumor cancers who are receiving standard checkpoint inhibitor therapy. The primary objective is to assess the impact of this nutritional supplement on natural killer cell activity in the blood of participants. Secondary objectives include evaluating immunologic effects, archiving stool specimens for future studies, and assessing any potential toxicities associated with the supplement. The trial aims to gather data that may clarify the role of fermented wheat germ in enhancing cancer treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumor malignancies such as colorectal carcinoma, lung non-small cell carcinoma, melanoma, and renal cell carcinoma who are eligible for checkpoint inhibitor therapy.

Not a fit: Patients with solid tumors not eligible for checkpoint inhibitor therapy or those with a life expectancy of less than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how fermented wheat germ may enhance immune responses in cancer patients undergoing immunotherapy.

How similar studies have performed: While there is limited documented evidence on the therapeutic effects of fermented wheat germ, the study explores a novel approach in conjunction with established immunotherapy treatments.

Eligibility criteria

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

Where this trial is running

Sacramento, California

• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (Recruiting)

Study contacts

• Principal investigator: Joseph M Tuscano — University of California, Davis

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 v8