Fiber to boost gut bacteria and immunotherapy response in advanced melanoma

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

This randomized, double-blind Phase 2 trial compares dried chicory root (fiber) to a placebo in patients with unresectable or metastatic melanoma who are beginning standard immunotherapy. The study aims to see if higher fiber intake shifts gut microbiota toward beneficial Bifidobacterium, potentially enhancing immune activity against cancer. Participants will provide stool samples and undergo regular disease assessments while on immunotherapy. The trial is conducted at Dutch centers with collaboration between Radboud University Medical Center and Wageningen University and Research. Outcomes will inform whether gut-targeted fiber can improve immunotherapy effectiveness in melanoma.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV disease
* Measurable disease according to RECIST 1.1 criteria
* Age ≥ 18 years
* Starting standard-of-care treatment with ICI in first line
* Written informed consent must be given
* Able to read and understand Dutch or English
* Able to comply with study procedures (e.g. willing to provide fecal samples)

Exclusion Criteria:

* Symptomatic brain metastases
* Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago
* Use of systemic immunosuppressive medications
* Use of laxatives up to 1 week prior to start of ICI
* Use of supplements that alter bowel function or gut microbiota such as fibers/prebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICI
* Use of antibiotics up to 1 months prior to start of ICI
* Use of proton pumps inhibitors (PPI's) up to 3 months prior to start of ICI
* Pregnant or lactating
* Current participation in another clinical trial requiring the use of study medication
* Has a known allergy to plants such as lettuce, sage, tarragon, chicory, artichoke, chamomile, daisy, or sunflower.
* Has a medical history of gastrointestinal resection (appendectomy is allowed)
* Has active inflammatory bowel disease

Where it's running

• Medical Oncology
  Nijmegen, Gelderland, Netherlands Recruiting
• Universitair Medisch Centrum Groningen
  Groningen, Provincie Groningen, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Kalijn Bol, dr.
• Email: Kalijn.Bol@radboudumc.nl
• Phone: +31 243618800

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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.