The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced … (NCT05967533) | Clinical Trial Compass
SuspendedPhase 1
The Immune Effects of Fermented Wheat Germ Nutritional Supplementation in Patients With Advanced Solid Tumor Cancers Being Treated With Standard of Care Checkpoint Inhibitors
Stopped: For internal interim analysis
United States100 participantsStarted 2023-06-02
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Prior allogeneic bone marrow transplantation or solid organ transplantation
* Chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosourea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently listed as suspended — do you know why it was suspended, and does that affect whether it might be worth revisiting in the future?
2Since this is a Phase 1 trial looking at fermented wheat germ as a supplement added to checkpoint inhibitor therapy, does that mean the main focus is on safety and immune effects rather than proving it actually shrinks tumors?
3The trial is measuring natural killer cell activity as its primary outcome — what would it mean for my treatment if my NK cell activity changed, and is that a reliable sign that the supplement is actually helping?
4Given that enrollment is suspended, is my standard checkpoint inhibitor treatment on its own still the best path forward for my specific cancer type and stage right now?
5Are there any known interactions between fermented wheat germ supplements and the checkpoint inhibitor I'm already on or being considered for, that I should be aware of even outside of this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.