Study of a High-Fiber Food Box to Reduce Side Effects from Immunotherapy in Solid Tumor Patients

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.

Food Intervention to Reduce Immunotherapy ToXicity