RecruitingNot ApplicableNCT05832606
Food Intervention to Reduce Immunotherapy ToXicity
Sponsor
Universitair Ziekenhuis Brussel
Enrollment
60 participants
Start Date
Jan 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria3
- no oral intake possible.
- probiotic use and unwillingness to stop during the trial.
- combination therapy with chemotherapy or targeted agents.
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Interventions
OTHERFood box containing 30 different plants
Food boxes during first 12 weeks of therapy. Clinical follow-up until end of immunotherapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05832606
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