Adding high-fiber dried chicory root after surgery for intermediate- to high-risk cutaneous melanoma.

Measuring Effects of High-fiber Dried Chicory Root on the Gut Microbiota of Patients With an Intermediate to High-risk Cutaneous Melanoma: an Explorative Study

Try whether taking a daily high-fiber dried chicory root supplement (WholeFiber) for six weeks changes gut short-chain fatty acids, gut microbes, and immune cells in people who have had surgery for intermediate- to high-risk stage II cutaneous melanoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Medical Center Groningen (Academic / other)
• Locations: 1 site (Groningen, Provincie Groningen)
• Trial ID: NCT07206017 on ClinicalTrials.gov

What this trial studies

This interventional study gives adults who completed surgery for intermediate- to high-risk stage II cutaneous melanoma a daily prebiotic supplement of dried chicory root (WholeFiber) for six weeks. Stool and blood samples will be collected before and after the supplementation to measure fecal short-chain fatty acid (SCFA) levels, gut microbial composition, and peripheral immune cell profiles. People with conditions that affect the gut or immune system, those on concurrent adjuvant therapy, or with intestinal stomas are excluded. The study takes place at the University Medical Center Groningen and requires participants who can read and speak Dutch and travel to the site for visits.

Who should consider this trial

Good fit: Adults (≥18) who speak Dutch, have completed surgical treatment for intermediate- to high-risk stage II cutaneous melanoma, are not receiving adjuvant therapy, and can travel to the UMCG for study visits.

Not a fit: People with medical conditions that affect the gut or immune system (for example type 2 diabetes, inflammatory bowel disease, celiac disease, or recent pancreatitis), those with an ileostomy or colostomy, or those receiving adjuvant therapy would not be expected to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could identify a simple dietary supplement that favorably shifts gut SCFAs and immune markers, which may support recovery and long-term outcomes after melanoma surgery.

How similar studies have performed: Prebiotic fibers such as chicory-derived inulin have been shown in other populations to increase fecal SCFAs and modify gut microbiota, but applying this approach to immune changes after melanoma surgery is largely untested.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years;
* The participant understands the study and can provide written informed consent;
* The participant received surgical treatment of an intermediate to high-risk cutaneous melanoma (T2a/N1, T2b, T3a, T3b, T4a, T4b, N0 or N+, M0 stadium without evidence of disease);
* Being able to read and speak Dutch;
* Willing to come to the UMCG for practical reasons (visiting the study site);
* Willing to continue their regular lifestyle patterns during the study.

Exclusion Criteria:

* Receiving concurrent adjuvant treatment, adjuvant treatment after the study period is allowed.
* Having a medical history that may impact study outcomes, such as a diagnosis of diabetes mellitus type 2, heart disease, renal disease, autoimmune disease;
* Any clinically significant or unstable medical disorder involving the gut, including celiac disease, inflammatory bowel disease, short-bowel syndrome or acute/chronic pancreatitis;
* Having an ileostomy or colostomy, as this greatly impacts bowel function and gut microbial composition;
* Use of antibiotics in the 3 months prior participation in the study;
* Use of prednisolone or other immunosuppressive medication;
* Use of tube feeding or sib-feeding;
* Being pregnant or lactating;
* Participation in another interventional study at the same time;
* Unable or unwilling to comply to study rules.

Where this trial is running

Groningen, Provincie Groningen

• Umcg — Groningen, Provincie Groningen, Netherlands (Recruiting)

Study contacts

• Principal investigator: G. A.P. Hospers, MD, PhD — University Medical Center Groningen
• Study coordinator: G. A.P. Hospers, MD, PhD

Conditions Melanoma, Stage II