Dietary fiber intervention to reduce immunotherapy side effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The FORX trial aims to determine if increasing dietary fiber intake through weekly boxes of 30 different plants can reduce immune-related adverse events (irAEs) in patients with solid tumors undergoing immune checkpoint inhibitor therapy. This innovative approach is based on the premise that a diverse gut microbiome, supported by a fiber-rich diet, can enhance tolerance to immunotherapy. Participants will receive these food boxes for the first 12 weeks of their treatment, and their stool and blood samples will be analyzed to understand the relationship between diet, gut microbiome, and irAEs. The trial seeks to provide actionable dietary recommendations to improve patient outcomes and quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• UZ Brussel
  Jette, Belgium Recruiting

Study contacts

• Principal investigator: Sandrine Aspeslagh, MD PhD — Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel)
• Study coordinator: Marthe Verhaert, MD
• Email: marthe.verhaert@uzbrussel.be
• Phone: +3224749480

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.