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Advanced Colorectal CarcinomaPhase 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

A Phase 1 study testing Fermented Wheat Germ Extract in people with Advanced Colorectal Carcinoma and Advanced Lung Non-Small Cell Carcinoma, run by University of California, Davis at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fermented Wheat Germ Extract
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
2 Jun 2023to Dec 2027
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: 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 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.

Read the detailed description

PRIMARY OBJECTIVE: I. To assess the effect of fermented wheat germ (FWG) nutritional supplementation on natural killer (NK) cell killing activity in peripheral blood of cancer patients being treated with standard of care (SOC) immunotherapy who have voluntarily decided to take the FWG nutritional supplement.

SECONDARY OBJECTIVES:

  1. To assess immunologic effects of FWG in subjects with cancer treated with checkpoint inhibitor (CPi)-based therapy.

II. To archive stool specimens of subjects with cancer treated with CPi-based therapy for future non-interventional studies for subsequent analysis at completion of study.

III. To evaluate toxicities of FWG in subjects with cancer treated with checkpoint inhibitor (CPi)-based therapy.

IV. To assess immunologic effects of FWG in patients with cancer treated with CPi immune-oncology-based therapy (Immune Correlates).

Being tested
Fermented Wheat Germ Extract
Medical subject headings
Colorectal Neoplasms, Lung Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fermented Wheat Germ ExtractDrug

    Also called Avemar, fermented wheat germ, FWG, FWGE

    Given orally (PO)

Study groups in NCT05967533
Study groupRoleWhat they receive
Fermented wheat germExperimentalPatients 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.
Receives: Drug: Fermented Wheat Germ Extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Natural killer (NK) cell killing activity

    Proportion of patients with 20% increase of NK cell killing activity measured ex vivo on day 4 (after fermented wheat germ food supplementation only) compared to the baseline values, will be calculated, along with 95% exact confidence intervals, for each tumor type. Will also conduct a pooled analysis using data from all tumor types.

    Measured: From baseline to Day 4

Secondary outcomes (6)

  1. NK cell activation

    Production of interferon-gamma (IFNgamma), expression of activation markers (CD69) and degranulation (CD107a), a one-sided paired t-test will be used for comparison with the baseline values, and a p value of < 0.05 will be regarded as statistically significant. Data transformation will be carried out as needed to better meet the normality assumption of t-tests.

    Measured: Baseline to day 57

  2. Adverse events

    Number of participants experiencing treatment-related adverse events (AE), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

    Measured: Baseline until 90 day after the last dose of study treatment.

  3. Immunologic effects of FWG (Immune Correlates): distribution of mononuclear cell subsets

    Percentage of mononuclear cell subsets in peripheral blood mononuclear cells (PBMC) by a multi-parameter fluorescence-activated cell sorting (FACS).

    Measured: Baseline to day 57

  4. Immunologic effects of FWG (Immune Correlates): assay of T cell proliferation, cytokine production and cytotoxic lymphocyte (CTL) activity

    CTL activity will be assessed by using ELISpot Assay to measure percentage of IFN-gamma producing cluster of differentiation 8 (CD8)+T cells as a percentage of peripheral blood mononuclear cells (PBMC).

    Measured: Baseline to day 57

  5. Immunologic effects of FWG (Immune Correlates): T-reg cell function

    Percentage change of interleukin-10 (IL-10), IL-4, transforming growth factor β (TGF-β), IL-2, tumor necrosis factor alpha (TNF-α), and interferon gamma (IFN-γ) by multi-parameter fluorescence-activated cell sorting (FACS) analyses from isolated cluster of differentiation (CD)4+CD25+ FoxP3+T cells

    Measured: Baseline to day 57

  6. Immunologic effects of FWG (Immune Correlates): serum cytokines analysis

    Percentage change in cytokines and growth factors (including interleukin-1 [IL-1], IL-2, IL-4, IL-5, IL-6, IL-7, IL-10, IL-12, IL-17, tumor necrosis factor [TNF], INF-γ, transforming growth factor-beta [TGF-beta], granulocyte-macrophage colony-stimulating factor [GM-CSF], platelet-derived growth factor [PDGF], and vascular endothelial growth factor [VEGF]) in the serum of patients using Luminex assay for immunologic analytes.

    Measured: Baseline to day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start2 Jun 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Why it stopped: For internal interim analysis

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05967533
Sponsor's protocol ID
UCDCC#304
Other IDs
NCI-2023-04604, UCDCC#304, P30CA093373
Status last verified
Jun 2026
First submitted
29 Jun 2023
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fermented Wheat Germ Extract in people with Advanced Colorectal Carcinoma and Advanced Lung Non-Small Cell Carcinoma, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Natural killer (NK) cell killing activity (time frame: From baseline to Day 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05967533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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