Trial Parameters
Condition Immune-related Adverse Event
Sponsor Universitair Ziekenhuis Brussel
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-01-01
Completion 2026-07-31
All Conditions
Interventions
Food box containing 30 different plants
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.
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