Dietary fiber intervention to reduce immunotherapy side effects
Food Intervention to Reduce Immunotherapy ToXicity
This study is testing if eating more fiber from a variety of plants can help people with solid tumors have fewer side effects from their immunotherapy treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Jette) |
| Trial ID | NCT05832606 on ClinicalTrials.gov |
What this trial studies
The FORX trial aims to determine if increasing dietary fiber intake through weekly boxes of 30 different plants can reduce immune-related adverse events (irAEs) in patients with solid tumors undergoing immune checkpoint inhibitor therapy. This innovative approach is based on the premise that a diverse gut microbiome, supported by a fiber-rich diet, can enhance tolerance to immunotherapy. Participants will receive these food boxes for the first 12 weeks of their treatment, and their stool and blood samples will be analyzed to understand the relationship between diet, gut microbiome, and irAEs. The trial seeks to provide actionable dietary recommendations to improve patient outcomes and quality of life.
Who should consider this trial
Good fit: Ideal candidates are patients with solid tumors who are starting treatment with anti-PD1 or anti-CTLA4 antibodies.
Not a fit: Patients who cannot take oral intake or are currently using probiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of side effects from immunotherapy, enhancing patient quality of life and treatment adherence.
How similar studies have performed: While the approach of dietary intervention in this context is novel, previous studies have indicated that dietary diversity can positively influence gut microbiome health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * solid tumor starting anti-programmed cell death protein 1 (anti-PD1) and/or anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA4) antibodies as part of standard of care. * able to sign informed consent. Exclusion Criteria: * no oral intake possible. * probiotic use and unwillingness to stop during the trial. * combination therapy with chemotherapy or targeted agents.
Where this trial is running
Jette
- UZ Brussel — Jette, Belgium (Recruiting)
Study contacts
- Principal investigator: Sandrine Aspeslagh, MD PhD — Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel)
- Study coordinator: Marthe Verhaert, MD
- Email: marthe.verhaert@uzbrussel.be
- Phone: +3224749480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.