Fermented Wheat Germ Extract for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Davis

Must be taking: Checkpoint inhibitors

Must not be taking: Immunosuppressants, Immunostimulatory agents

Disqualifiers: Autoimmune disorders, Organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if fermented wheat germ, a nutritional supplement, can boost the immune response when combined with checkpoint inhibitors—standard cancer treatments that help the immune system fight cancer cells. The study targets individuals with advanced solid tumors, such as lung, kidney, skin, colon, and certain breast cancers, who are already receiving checkpoint inhibitors. It suits those who can swallow the supplement and are not currently using fermented wheat germ or similar therapies. Participants must have a diagnosis of the specified cancers and be willing to try this new combination to see if it enhances their ongoing cancer treatment. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new combination therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but certain medications like immunosuppressive drugs and some cancer therapies must be stopped before joining. It's best to discuss your specific medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that fermented wheat germ extract is likely to be safe for humans?

Research has shown that fermented wheat germ extract, also known as Avemar, is generally safe. Studies have found that even at high doses, it does not cause harmful effects. People have safely used doses between 8.5 to 9 grams. No reports indicate it causes damage to cells or DNA, meaning it doesn't lead to genetic mutations or toxic effects.

Some believe fermented wheat germ extract might aid in cancer treatment, but more research is needed to confirm this. Current use suggests it is well-tolerated as a supplement. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fermented Wheat Germ Extract is unique because it introduces a natural, dietary approach to cancer treatment, which is quite different from conventional therapies like chemotherapy and immunotherapy. Researchers are excited about it because it has a novel mechanism of action, potentially modulating the immune system to enhance the effects of existing treatments like checkpoint inhibitors. Unlike traditional cancer treatments that often come with severe side effects, this extract is taken orally and is derived from a natural source, which could offer a gentler alternative for patients.

What evidence suggests that fermented wheat germ extract might be an effective treatment for cancer?

Research suggests that fermented wheat germ extract, which participants in this trial will receive, might help fight cancer. Studies have shown it can enhance the immune system's ability to attack cancer cells, especially when combined with immunotherapy, a treatment that aids the immune system in fighting cancer. Lab tests have demonstrated its ability to kill various cancer cells, including those from breast, colon, and testicular cancers. However, evidence from human studies remains limited, so its effectiveness in people is not fully understood. Some reports indicate it might improve survival and response to other cancer treatments. ^{2 6 7 8 9}

Who Is on the Research Team?

Joseph M. Tuscano

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

Adults with advanced solid tumors (like lung, kidney, skin cancers) who are already on checkpoint inhibitors can join. They must be able to swallow pills, have a life expectancy over 6 months, and use birth control. People can't join if they've had certain vaccines recently, are already taking the supplement being tested or other immune treatments, have uncontrolled illnesses or allergies to similar compounds.

Inclusion Criteria

I agree to use birth control or abstain from sex during and for 5 months after the study.

I can swallow pills.

I agree to use birth control and not donate sperm while on FWG and for 90 days after.

Exclusion Criteria

I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

Any medical condition that in the opinion of the investigator would interfere with the patient's safety or compliance while on trial

I haven't had chemotherapy or radiotherapy in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive fermented wheat germ supplementation and standard of care checkpoint inhibitor therapy

8 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fermented Wheat Germ Extract

Trial Overview This trial is testing fermented wheat germ as a nutritional supplement alongside standard cancer immunotherapy drugs called checkpoint inhibitors. Researchers want to see if it improves the immune system's response against cancer in patients with advanced solid tumors.

How Is the Trial Designed?

Group I: Fermented wheat germ Experimental Treatment 1 Intervention

Patients 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.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Fermented wheat germ extract (Avemar) has shown significant efficacy in supporting colorectal cancer treatment, with a study of 170 patients revealing lower rates of new recurrences (3.0% vs. 17.3%) and new metastases (7.6% vs. 23.1%) compared to standard therapy alone.

In a cohort of 30 patients post-surgery, those receiving the extract had no new distant metastases after 9 months, while 4 out of 18 in the control group did, highlighting its potential as a supportive therapy with mild side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fermented wheat germ extract in the supportive therapy of colorectal cancer]. Farkas, E.[2009]

Fermented wheat germ extract (Avemar) shows promising potential as an adjunct therapy in cancer treatment, with laboratory studies indicating it can promote cancer cell death while sparing normal cells, and may enhance the effectiveness of conventional treatments like chemotherapy and radiotherapy.

Initial human trials suggest that Avemar could help slow cancer progression and improve patients' quality of life, although more extensive clinical research is needed to fully establish its efficacy and safety in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of fermented wheat germ extract as an adjunct therapy in the treatment of cancer: A systematic review. Yeend, T., Robinson, K., Lockwood, C., et al.[2022]

Fermented wheat germ extract (FWGE) has shown significant antiproliferative effects against tumor cells and can enhance the effectiveness of anticancer drugs, particularly in melanoma patients treated with dacarbazine, leading to improved progression-free survival and overall survival.

FWGE not only helps in fighting cancer but also improves the quality of life for patients, suggesting its potential as a beneficial non-prescription supplement for cancer treatment, although more extensive clinical trials are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fermented wheat germ extract--nutritional supplement or anticancer drug? Mueller, T., Voigt, W.[2021]

Fermented wheat germ extract (FWGE) demonstrated an average IC50 value of 10 mg/ml across nine human cancer cell lines, indicating its potential effectiveness in inhibiting cancer cell growth.

FWGE not only caused cell damage through oxidative stress but also exhibited cytostatic and growth delay effects by impairing glucose utilization, which may lead to autophagy, suggesting a novel mechanism of action in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiproliferative and antimetabolic effects behind the anticancer property of fermented wheat germ extract. Otto, C., Hahlbrock, T., Eich, K., et al.[2018]

In a randomized phase II clinical trial involving high-risk skin melanoma patients, the addition of fermented wheat germ extract (FWGE) to standard dacarbazine chemotherapy significantly improved both progression-free survival (PFS) and overall survival (OS) over a 7-year follow-up period.

Patients receiving FWGE had a mean PFS of 55.8 months and a mean OS of 66.2 months, compared to 29.9 months and 44.7 months in the control group, respectively, indicating that FWGE may enhance the effectiveness of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant fermented wheat germ extract (Avemar) nutraceutical improves survival of high-risk skin melanoma patients: a randomized, pilot, phase II clinical study with a 7-year follow-up. Demidov, LV., Manziuk, LV., Kharkevitch, GY., et al.[2013]

AVEMAR, a fermented wheat germ extract, demonstrated significant antiproliferative effects on human oral squamous carcinoma cells, with IC50 values indicating effective inhibition of cell viability at concentrations of 1.19 mg/ml and 0.98 mg/ml after 24 and 48 hours, respectively.

The extract also inhibited the migration and invasion of cancer cells by suppressing specific signaling molecules like MMP-2 and u-PA, suggesting its potential as a preventive agent for oral cancer beyond its current use in gastrointestinal cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory Effects of AVEMAR on Proliferation and Metastasis of Oral Cancer Cells. Yang, MD., Chang, WS., Tsai, CW., et al.[2017]

Avemar, a wheat germ extract, has demonstrated significant anticancer activity by disrupting glucose metabolism and modulating kinase expressions, making it a promising supplement for cancer patients.

In vivo studies show that Avemar enhances immune system activity, including stimulating natural killer (NK) cells and increasing tumor cell apoptosis, suggesting a multifaceted mechanism of action beyond a single active ingredient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avemar (wheat germ extract) in cancer prevention and treatment. Telekes, A., Hegedus, M., Chae, CH., et al.[2011]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3179707/

Fermented wheat germ extract - nutritional supplement or ... In a large in vitro anticancer drug screen we found FWGE to possess potential antitumor activity in colon, testis, thyroid, ovary, NSCLC, breast, gastric, head ...

2. health.ucdavis.edu health.ucdavis.edu/news/headlines/wheat-germ-may-boost-immunotherapy-in-cancer-patients/2025/06

Wheat germ may boost immunotherapy in cancer patients Wheat germ may help bolster the natural cancer-fighting abilities system in patients who are getting treated with immunotherapy.

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1677464/full

A Systematic Review on the Health Effects of Fermented ... While the findings suggest that FWGE may possess therapeutic potential, especially in oncology, the strength of evidence remains limited. Of the six included ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4036555/

Characterizing the efficacy of fermented wheat germ extract ... FWGE has been evaluated in vitro and shown to induce apoptosis in many cancer cell types, including leukemia, melanoma, breast, colon, testicular, head and neck ...

5. cancerchoices.org cancerchoices.org/therapy/fermented-wheat-germ-extract/for-health-professionals/

Fermented Wheat Germ Extract: Are you a health ... This dietary supplement may improve survival and your response to chemotherapy or radiotherapy, notably among people with colon cancer.

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1500/fermented-wheat-germ-extract

Fermented Wheat Germ Extract - Uses, Side Effects, and ... When taken by mouth: Fermented wheat germ extract is possibly safe. A specific wheat germ extract (Avemar) has been used safely in doses of 8.5-9 grams once or ...

7. mskcc.org mskcc.org/cancer-care/integrative-medicine/herbs/wheat-germ-extract

Wheat germ extract Fermented wheat germ may improve quality of life in cancer patients, but data is limited and more studies are needed.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20155632/

Avemar (wheat germ extract) in cancer prevention and ... Avemar is a nontoxic wheat germ extract registered as a special nutriment for cancer patients in Hungary. It shows potent anticancer activity on cell lines.

9. journals.sagepub.com journals.sagepub.com/doi/10.1080/10915810701369709

Safety Studies Regarding a Standardized Extract ... Studies show Avemar pulvis is safe for dietary use, with no adverse effects in high doses, and no evidence of mutagenicity or genotoxicity. It is considered ...