Food Intervention to Reduce Immunotherapy ToXicity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
no oral intake possible.
probiotic use and unwillingness to stop during the trial.
combination therapy with chemotherapy or targeted agents.
Trial design
Design model
Single group
Treatments tested in this trial
Food box containing 30 different plants
Other interventionFood boxes during first 12 weeks of therapy. Clinical follow-up until end of immunotherapy.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: High Fiber dietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of performing a dietary intervention trial in our center
Recruitment will be temporarily held after 10 patients to assess compliance with protocol and dietary intervention. If at least 7/10 patients are able to complete the 12 weeks according to protocol, the trial will be considered feasible and recruitment will continue.
Time frame
12 weeks2
Incidence of immune related adverse events
Assess incidence and grade of irAEs throughout the 12-week intervention phase and until end of ICI treatment by frequency counts and grade. Comparison with historical control.
Time frame
up to 24 monthsSecondary outcomes
1
Response rate
Measure objective response rate at 12 weeks and progression free survival at week 12, 24 and 48 according to RECIST 1.1. Observational comparison with historical control.
Time frame
up to 48 weeks2
Quality of life
Assess change in quality of life following dietary intervention using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Hospital Anxiety and Depression Score (HADS) questionnaire at baseline, at 6 weeks and at 12 weeks.
Time frame
12 weeks3
Changes in gut microbiota
Assess changes in gut microbiota composition following dietary intervention. Assess microbiota signatures associated with irAEs.
Time frame
12 weeks and in case of an irAE up to 48 months4
Assess changes in cytokines and immune cell subsets associated with irAEs
Blood samples will be collected at baseline, every 4 weeks for 12 weeks during the intervention and in case of toxicity. Based on published data, the investigators will primarily focus on Th17-related cytokines (IL-6, IL-17, IL-23, IFN-gamma). PBMC will be analysed using high dimensional flow cytometry, using panels to measure different immune cell subsets (T cells and subtypes, B cells, among which regulatory B cells). Analysis using regression models.
Time frame
12 weeks and in case of an irAE up to 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov