2185TiP - Belgian FORX trial: FOod interventions to Reduce immunotherapy toXicity

Background

Immune checkpoint inhibitor (ICI) therapy has revolutionized cancer treatment but can cause immune related adverse events (irAEs) which we currently do not know how to prevent. These irAEs influence 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 American Gut project, an international microbiome study, showed that healthy volunteers who ingested at least 30 different plants (vegetables, fruits, nuts) weekly had a more diverse microbiome than those who consumed 10 or less. A fibre-rich diet has been associated with improved outcome of ICI treatment and with reductions of perceived stress.

Trial design

The FORX trial investigates whether altering the composition of the gut microbiome can improve ICI tolerance. In our tertiary reference centre, we are supplementing the diets of solid tumour patients starting ICI with weekly boxes containing 30 different plants during the first 12 weeks of their treatment. The increased fibre 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. Baseline physical activity and body composition will be assessed given recent retrospective data showing synergistic effects of exercise, body composition and ICI therapy. Quality of life questionnaires will be completed at baseline, week 6 and week 12 throughout the intervention. The FORX trial is the first prospective trial to translate the cited retrospective findings into a concrete dietary advice. Our trial will provide valuable insights in the interaction between the gut microbiome, physical fitness and autoimmunity and serve as a basis for nutritional and probiotic advice. It will empower cancer patients and improve their quality of life.

Clinical trial identification

NCT05832606.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

UZ Brussel.

Disclosure

All authors have declared no conflicts of interest.