Food Intervention to Reduce Immunotherapy ToXicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Food box containing 30 different plants.
- Who it may be relevant to
- Registry conditions: Immune-related Adverse Event, Dietary Habits. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Immune checkpoint inhibitor (ICI) therapy has revolutionized cancer treatment but can give rise to immune related adverse events (irAEs) that are currently not preventable. These irAEs impact patients' quality of life and oncological treatment course. The gut plays an essential role in immune homeostasis and gut dysbiosis is implicated in (auto)inflammatory conditions. The FORX trial investigates whether the composition of the gut microbiome can be altered to improve ICI tolerance. It has been shown that healthy volunteers who ingest at least 30 different plants (vegetables, fruits, nuts) weekly, have a more diverse microbiome than those who consume 10 or less. A fiber-rich diet has been associated with improved outcome of ICI treatment. This trial is the first prospective trial to translate these findings into a concrete dietary advice. The diets of patients with a solid tumor who start ICI will be supplemented by weekly boxes containing 30 different plants during the first 12 weeks of their treatment. The increased fiber intake is expected to strengthen the gut microbiome and reduce the incidence of irAEs. Stool and blood samples will clarify the microbial and cytokine signatures associated with irAEs. The FORX trial will provide valuable insights in the interaction between the gut microbiome and autoimmunity and serve as a basis for nutritional advice and the development of targeted probiotics. It will empower cancer patients and improve their quality of life.
Interventions
- Other Food box containing 30 different plants
Food boxes during first 12 weeks of therapy. Clinical follow-up until end of immunotherapy.
Primary outcome measures
- Feasibility of performing a dietary intervention trial in our center [Time frame: 12 weeks]
- Incidence of immune related adverse events [Time frame: up to 24 months]
Secondary outcome measures (4)
- Response rate [Time frame: up to 48 weeks]
- Quality of life [Time frame: 12 weeks]
- Changes in gut microbiota [Time frame: 12 weeks and in case of an irAE up to 48 months]
- Assess changes in cytokines and immune cell subsets associated with irAEs [Time frame: 12 weeks and in case of an irAE up to 48 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- UZ Brussel — Jette
Identifiers
NCT: NCT05832606 · FORX01