Food Intervention to Reduce Immunotherapy ToXicity

Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · Apr 14, 2023

Keywords

ClinConnect Summary

The FORX trial is studying whether adding more dietary fiber to the diets of patients with solid tumors can help reduce side effects from a type of cancer treatment called immune checkpoint inhibitors. Participants in this trial will receive weekly boxes filled with 30 different types of plants, which are rich in fiber. This study aims to see if this dietary change can lower the chance of experiencing immune-related side effects, which can occur during immunotherapy.

To be eligible for the trial, participants should be between the ages of 65 and 74 and must be starting treatment with specific immunotherapy drugs known as anti-PD1 or anti-CTLA4. They also need to be able to sign a consent form to participate. However, people who cannot eat by mouth, are taking probiotics, or are receiving other cancer treatments like chemotherapy cannot join. If you participate, you can expect to receive healthy plant-based foods while helping researchers understand how diet might impact your treatment experience.

Gender

ALL

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.