Fermented Wheat Germ Extract for Cancer
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
12367How 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.
12346Eligibility 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.
+5 more
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.
+16 more
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Fermented wheat germExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California Davis Comprehensive Cancer CenterSacramento, CA
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Who Is Running the Clinical Trial?
University of California, DavisLead Sponsor
National Cancer Institute (NCI)Collaborator
References
[Fermented wheat germ extract in the supportive therapy of colorectal cancer]. [2009]The role of the product in the treatment of colorectal cancer is reviewed in the light of experimental and clinical results to date. The fermented wheat germ extract (code name: MSC, trade name: Avemar) registered as a dietary food for special medical purposes for cancer patients to complement the active oncotherapy, exerted a growth inhibitory effect in HCR-25 human colon carcinoma xenograft, and had a synergistic effect with 5-FU in mouse C-38 colorectal carcinoma. The product is capable of chemoprevention of colon carcinoma in F-344 rats. One of the most significant underlying mechanism is a highly cancer cell specific induction of caspase-3 mediated cleavage of PARP. In the frame of supportive therapy, fermented wheat germ extract proved to be efficient in the treatment of colorectal cancer in humans. 30 patients following radical operation were treated with standard postoperative therapy, 12 of them were given fermented wheat germ extract as additive treatment: following a 9 month long administration, no new distant metastases were detected, in contrast to 4 out 18 treated with standard therapy alone. Out of 34 patients following radical surgery and treated with chemotherapy, 17 who were given fermented wheat germ extract, achieved an improved survival rate. In the frame of a controlled multicenter open label cohort study, 170 colorectal cancer patients received anticancer therapies (chemo/radiotherapy) completed with fermented wheat germ extract in 66 of them. Results (fermented wheat germ extract vs. control): new recurrences: 3.0% vs. 17.3% (p
The effectiveness of fermented wheat germ extract as an adjunct therapy in the treatment of cancer: A systematic review. [2022]The objective of this review is to synthesise the best available evidence on effectiveness of fermented wheatgerm extract (Avemar) as an adjunct therapy to conventional cancer treatments such as surgery, chemotherapy, radiotherapy and hormone therapies, in the treatment of haematological and non-haematological cancers.
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]The fermented wheat germ extract (FWGE) nutraceutical (Avemar), manufactured under "good manufacturing practice" conditions and, fulfilling the self-affirmed "generally recognized as safe" status in the United States, has been approved as a "dietary food for special medical purposes for cancer patients" in Europe. In this paper, we report the adjuvant use of this nutraceutical in the treatment of high-risk skin melanoma patients.
Fermented wheat germ extract--nutritional supplement or anticancer drug? [2021]Fermented wheat germ extract (FWGE) is a multisubstance composition and, besides others, contains 2-methoxy benzoquinone and 2, 6-dimethoxy benzoquinone which are likely to exert some of its biological effects. FWGE interferes with anaerobic glycolysis, pentose cycle and ribonucleotide reductase. It has significant antiproliferative effects and kills tumor cells by the induction of apoptosis via the caspase-poly [ADP-ribose] polymerase-pathway. FWGE interacts synergistically with a variety of different anticancer drugs and exerted antimetastatic properties in mouse models. In addition, FWGE modulates immune response by downregulation of MHC-I complex and the induction of TNF-α and various interleukins. Data in the F-344 rat model provide evidence for a colon cancer preventing effect of FWGE.Clinical data from a randomized phase II trial in melanoma patients indicate a significant benefit for patients treated with dacarbazine in combination with FWGE in terms of progression free survival (PFS) and overall survival (OS). Similarly, data from studies in colorectal cancer suggested a benefit of FWGE treatment. Besides extension of OS and PFS, FWGE improved the quality of life in several studies.
Inhibitory Effects of AVEMAR on Proliferation and Metastasis of Oral Cancer Cells. [2017]Oral cancer is keeping its 4th rank on the death causing cancers among Taiwan males, and its metastatic and recurrent rates remain high and a life-threatening issue to the citizens. Fermented wheat germ extract (AVEMAR) is used in clinical cancer nutritional therapy in gastrointestinal cancers but not in oral cancer yet. In this study, the potential of AVEMAR to inhibit tumor proliferation and metastasis of oral cancer was first investigated. Antiproliferative activity of AVEMAR was determined in human oral squamous carcinoma SCC-4 cells by MTT methodology. Wound-healing migration, transwell invasion, and Western blotting assays were carried out to examine the in vitro antimetastatic effects and involved signaling molecules for AVEMAR in oral cancer cells. AVEMAR at 0.2-1.6 mg/ml significantly inhibited the cell viability with IC50 values of 1.19 and 0.98 mg/ml for 24-h and 48-h treatment. Furthermore, AVEMAR could induce cell apoptosis and inhibit the migration and invasion of metastatic SCC-4 cells at a similar dose range. Notably, AVEMAR suppressed the expression of matrix metalloproteinase (MMP)-2 and urokinase plasminogen activator (u-PA), but not MMP-1 or MMP-9, in SCC-4 cells. These results strongly support the antiproliferation and in vitro antimetastatic capacity of AVEMAR which may extend its contributions from cancer nutrition supplements to preventive agent for oral cancer.
Antiproliferative and antimetabolic effects behind the anticancer property of fermented wheat germ extract. [2018]Fermented wheat germ extract (FWGE) sold under the trade name Avemar exhibits anticancer activity in vitro and in vivo. Its mechanisms of action are divided into antiproliferative and antimetabolic effects. Its influcence on cancer cell metabolism needs further investigation. One objective of this study, therefore, was to further elucidate the antimetabolic action of FWGE. The anticancer compound 2,6-dimethoxy-1,4-benzoquinone (DMBQ) is the major bioactive compound in FWGE and is probably responsible for its anticancer activity. The second objective of this study was to compare the antiproliferative properties in vitro of FWGE and the DMBQ compound.
Avemar (wheat germ extract) in cancer prevention and treatment. [2011]Many healthy foods are derived from wheat germ. The molecular composition of these products, however, greatly differs as shown by normal-phase HPLC-mass spectrometry analysis; thus, experimental data obtained by one of them is not necessarily true for the other. 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 by deeply interfering with glucose metabolism and affecting expressions of several kinases. In in vivo experimental models, Avemar is also effective by enhancing the activity of the immune system such as stimulating NK cell activity (by reducing MHC I molecule expression), enhancing TNF secretion of the macrophages, increasing ICAM 1 molecule expression on the vascular endothelial cells. All of these lead to apoptosis of tumor cells. The wide range of biological activity of Avemar probably cannot be explained by only one active ingredient. Since there are numerous experimental data and the clinical benefit repeatedly confirmed Avemar can be one of the most potent and best researched food supplements available for cancer patients.