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Fermented Wheat Germ Extract for Cancer
Phase 1
Recruiting
Led By Joseph M Tuscano
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be able to swallow study treatment
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 CPi-based therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline until 90 day after the last dose of study treatment.
Awards & highlights
Study Summary
This trial tests if dietary supplement fermented wheat germ boosts the effectiveness of cancer treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since fermented wheat germ is a nutritional supplement rather than a drug, specific side effects aren't well-documented but could include digestive issues due to its fiber content. Allergic reactions may occur in those sensitive to gluten or related compounds.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow pills.
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My cancer is one of NSCLC, RCC, melanoma, CRC, or TNBC and can be treated with CPi therapy.
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I am 18 years old or older.
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I can take care of myself but might not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline until 90 day after the last dose of study treatment.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline until 90 day after the last dose of study treatment.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Natural killer (NK) cell killing activity
Secondary outcome measures
Immunologic effects of FWG (Immune Correlates): T-reg cell function
Immunologic effects of FWG (Immune Correlates): assay of T cell proliferation, cytokine production and cytotoxic lymphocyte (CTL) activity
Immunologic effects of FWG (Immune Correlates): distribution of mononuclear cell subsets
+3 moreTrial Design
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.
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Who is running the clinical trial?
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,419 Total Patients Enrolled
7 Trials studying Melanoma
388 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,341 Total Patients Enrolled
557 Trials studying Melanoma
193,090 Patients Enrolled for Melanoma
Joseph M TuscanoPrincipal InvestigatorUniversity of California, Davis
6 Previous Clinical Trials
169 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I haven't had chemotherapy or radiotherapy in the last 2 weeks.I agree to use birth control or abstain from sex during and for 5 months after the study.I haven't taken any immune-boosting drugs like interferon or interleukin in the last 6 weeks.I can swallow pills.I have not had a live flu vaccine in the last 4 weeks.I agree to use birth control and not donate sperm while on FWG and for 90 days after.I haven't taken strong immune system suppressing drugs in the last 14 days, except for allowed types like inhaled or local steroids.I have not had serious autoimmune or inflammatory disorders in the last 3 years, except for stable thyroid issues, vitiligo, alopecia, or untreated psoriasis.My cancer is one of NSCLC, RCC, melanoma, CRC, or TNBC and can be treated with CPi therapy.I do not have any severe illnesses or social situations that could affect my safety or participation in the study.I am currently taking FWG.I have active tuberculosis.I am 18 years old or older.I am not pregnant or breastfeeding.I am on bisphosphonate therapy for reasons other than high calcium levels.I can take care of myself but might not be able to do active work.You had bad side effects from immunotherapy treatments before.I have had a bone marrow or organ transplant in the past.You are expected to live for at least 6 more months.You have had allergic reactions to similar medicines or substances like gluten.I haven't had major surgery in the last 28 days and don't expect to need one during the study.You have not fully recovered from side effects caused by previous treatments, or have taken other experimental drugs recently.You have a history of specific lung conditions, or evidence of active lung inflammation on a CT scan. However, if you have well-controlled thyroid or type 1 diabetes, you are eligible to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Fermented wheat germ
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can the consumption of Fermented wheat germ be deemed as innocuous?
"The safety of fermented wheat germ is rated a 1, as the data to support its efficacy and security are still quite limited."
Answered by AI
Does this clinical research have any vacancies for participants?
"According to medical records hosted by clinicaltrials.gov, this trial is currently seeking participants and was originally posted on June 2nd 2023 with the most recent edits occurring on July 26th 2023."
Answered by AI
How many subjects are participating in this clinical experiment?
"Indeed, clinicaltrials.gov displays information that affirms this trial is presently seeking participants. Originally posted on June 2nd 2023 and modified on July 26th 2023, the study requires 100 patients to be recruited from 1 medical facility."
Answered by AI
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