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

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: g.a.p.hospers@umcg.nl
• Phone: +31 50 361 2821

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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.