Clinical trial NCT05832606: Food Intervention to Reduce Immunotherapy ToXicity
Official title: Food Intervention to Reduce Immunotherapy ToXicity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Immune-related Adverse Event
Dietary Habits
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The FORX interventional trial will be a monocentric single arm dietary intervention trial in 60 patients starting immune checkpoint inhibitor therapy for different types of cancer in both the adjuvant and metastatic setting.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: Feasibility of performing a dietary intervention trial in our center
timeFrame: 12 weeks
measure: Incidence of immune related adverse events
timeFrame: up to 24 months
Secondary outcomes:
measure: Response rate
timeFrame: up to 48 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Changes in gut microbiota
timeFrame: 12 weeks and in case of an irAE up to 48 months
measure: Assess changes in cytokines and immune cell subsets associated with irAEs
timeFrame: 12 weeks and in case of an irAE up to 48 months
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel)
name: Sandrine Aspeslagh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: