NCT05832606 Food Intervention to Reduce Immunotherapy ToXicity
| NCT ID | NCT05832606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Immune-related Adverse Event |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-01-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The FORX (Food intervention to Reduce immunotherapy toXicity) trial will assess whether supplementing dietary fiber intake by providing weekly boxes containing 30 different plants to patients with solid tumors starting immune checkpoint inhibitor therapy affects the incidence of immune related adverse events.
Eligibility 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.
Contact & Investigator
Sandrine Aspeslagh, MD PhD
PRINCIPAL INVESTIGATOR
Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel)
Frequently Asked Questions
Who can join the NCT05832606 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune-related Adverse Event. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05832606 currently recruiting?
Yes, NCT05832606 is actively recruiting participants. Contact the research team at marthe.verhaert@uzbrussel.be for enrollment information.
Where is the NCT05832606 trial being conducted?
This trial is being conducted at Jette, Belgium.
Who is sponsoring the NCT05832606 clinical trial?
NCT05832606 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Sandrine Aspeslagh, MD PhD at Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel). The trial plans to enroll 60 participants.