Actively Recruiting
Food Intervention to Reduce Immunotherapy ToXicity in Patients with Solid Tumors Starting Immune Checkpoint Inhibitor Therapy
Led by Universitair Ziekenhuis Brussel · Updated on 2025-03-26
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the effect of increasing dietary fiber intake on patients with solid tumors who are starting immune checkpoint inhibitor (ICI) therapy. ICI treatment, while effective against cancer, can cause immune related adverse events (irAEs) that affect quality of life and treatment course. This study aims to see if supplementing patients' diets with a variety of plants can reduce these side effects by improving gut microbiome diversity and immune tolerance. Participants will receive weekly boxes containing 30 different plants such as vegetables, fruits, nuts, and grains for the first 12 weeks of their ICI therapy. These boxes are provided according to seasonal availability and include recipes to help prepare the foods. The fiber intake will start at a minimum daily amount of 20 grams and gradually increase over the first four weeks. The intervention is delivered at home through an online supermarket. Throughout the study, patients will be monitored for immune related side effects, quality of life, changes in gut bacteria, and immune system markers through stool and blood samples. The study will assess how feasible the dietary intervention is and track the incidence of irAEs up to 24 months. Additional follow-up will measure treatment response and longer-term immune and microbiome changes for up to 48 months.
CONDITIONS
Brief Title
Food Intervention to Reduce Immunotherapy ToXicity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a solid tumor and starting anti-PD1 and/or anti-CTLA4 antibody treatment as part of standard care
- Ability to provide informed consent
- Age 18 years or older
You will not qualify if you...
- Unable to take food by mouth
- Currently using probiotics and unwilling to stop during the trial
- Receiving combination therapy with chemotherapy or targeted agents alongside immune checkpoint inhibitor treatment
- Unable or unwilling to comply with study procedures and diet requirements (implied by eligibility criteria but not explicitly stated in source, so omitted here as per instructions to not add information)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive weekly boxes containing 30 different plants to supplement their diet during the first 12 weeks of immune checkpoint inhibitor therapy to potentially reduce immune related adverse events.
Weekly visits for up to 12 weeks
Duration - Up to 24 months
Participants are followed clinically until the end of their immunotherapy treatment to monitor outcomes and immune related adverse events.
Visits as scheduled during immunotherapy treatment
Trial Site Locations
Total: 1 location
1
UZ Brussel
Jette, Belgium, 1090
Actively Recruiting
Research Team
M
Marthe Verhaert, MD
S
Sandrine Aspeslagh, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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