Food Intervention to Reduce Immunotherapy ToXicity

NCT05832606 | Recruiting

• 1 other identifier: FORX01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune-related Adverse Event; Dietary Habits

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Response rate

  up to 48 weeks

• Quality of life

  12 weeks

• Changes in gut microbiota

  12 weeks and in case of an irAE up to 48 months

• Assess changes in cytokines and immune cell subsets associated with irAEs

  12 weeks and in case of an irAE up to 48 months

Study Arms (1)

High Fiber diet

EXPERIMENTAL

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.

Other: Food box containing 30 different plants

Interventions

Food box containing 30 different plants OTHER

Food boxes during first 12 weeks of therapy. Clinical follow-up until end of immunotherapy.

High Fiber diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• no oral intake possible.
• probiotic use and unwillingness to stop during the trial.
• combination therapy with chemotherapy or targeted agents.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Sandrine Aspeslagh, MD PhD

  Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marthe Verhaert, MD

CONTACT

+3224749480; marthe.verhaert@uzbrussel.be

Sandrine Aspeslagh, MD PhD

CONTACT

sandrine.aspeslagh@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 27, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)