Food Intervention to Reduce Immunotherapy ToXicity (FORX01)

Universitair Ziekenhuis Brussel

Status: Enrolling

Conditions: Dietary Habits; Immune-related Adverse Event

Treatments: Other: Food box containing 30 different plants

Study type: Interventional

Funder types: Other

Identifiers

NCT05832606

FORX01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

High Fiber diet

Experimental group

Description:

During the first 12 weeks of immune checkpoint inhibitor therapy, patients will receive weekly boxes containing 30 different plants (vegetables, fruits, nuts, grains) according to seasonal availability following the Flemish Superior Health Council guidelines. Recipes will be added to inspire processing of the box. Boxes will be ordered at an online supermarket, who will deliver the boxes at patients' homes. Weekly follow-up will ensure a minimum daily intake of 20 g of fiber, progressively increasing over the first 4 weeks.

Treatment:

Other: Food box containing 30 different plants