Fermented Wheat Germ Extract for Cancer

Overseen by Joseph M. Tuscano

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests if a nutritional supplement called fermented wheat germ can help boost the immune system in patients with advanced solid tumors who are already receiving standard cancer treatments. The goal is to see if this supplement can improve the effectiveness of their current therapy by enhancing immune cell activity.

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.

What evidence supports the effectiveness of the treatment Fermented Wheat Germ Extract (FWGE) for cancer?

Research shows that Fermented Wheat Germ Extract (FWGE) can help improve survival rates and reduce cancer recurrence when used alongside standard cancer treatments. In studies, patients with colorectal cancer and high-risk skin melanoma who received FWGE had better outcomes compared to those who did not. ^{1 2 3 4 5}

Is fermented wheat germ extract safe for humans?

Fermented wheat germ extract (FWGE), also known as Avemar, is generally recognized as safe in the United States and is approved as a dietary food for special medical purposes for cancer patients in Europe. It is considered nontoxic and has been used in various studies without significant safety concerns. ^{1 2 3 6 7}

How is fermented wheat germ extract different from other cancer treatments?

Fermented wheat germ extract (FWGE) is unique because it is a dietary supplement that works alongside conventional cancer treatments to enhance their effectiveness. It has antiproliferative and antimetabolic effects, specifically targeting cancer cells and inducing apoptosis (programmed cell death) through a specific pathway. Additionally, FWGE has shown potential in preventing cancer recurrence and improving survival rates in patients. ^{1 2 3 4 6}

Research Team

Joseph M. Tuscano

Principal Investigator

University of California, Davis

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Fermented Wheat Germ Extract (Other)

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.

Participant Groups

Group I: Fermented wheat germ Experimental Treatment 1 Intervention

Patients receive fermented wheat germ 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+

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Hungary pubmed.ncbi.nlm.nih.gov

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

2. Australia pubmed.ncbi.nlm.nih.gov

The effectiveness of fermented wheat germ extract as an adjunct therapy in the treatment of cancer: A systematic review. [2022]

3. United States 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. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Fermented wheat germ extract--nutritional supplement or anticancer drug? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Inhibitory Effects of AVEMAR on Proliferation and Metastasis of Oral Cancer Cells. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Antiproliferative and antimetabolic effects behind the anticancer property of fermented wheat germ extract. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Avemar (wheat germ extract) in cancer prevention and treatment. [2011]