Dietary Habits Clinical Trial
— FORX01Official title:
Food Intervention to Reduce Immunotherapy toXicity
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2026 |
Est. primary completion date | July 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel | Jette |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 weeks | |
Primary | 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. | up to 24 months | |
Secondary | 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. | up to 48 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | Changes in gut microbiota | Assess changes in gut microbiota composition following dietary intervention. Assess microbiota signatures associated with irAEs. | 12 weeks and in case of an irAE up to 48 months | |
Secondary | 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. | 12 weeks and in case of an irAE up to 48 months |
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