Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.

Not Applicable

Recruiting

• Conditions: Melanoma, Stage II

• Registration Number: NCT07206017
• Lead Sponsor: University Medical Center Groningen

Brief Summary

Exploring the effect of supplementation with daily addition of prebiotic dried chicory root (WholeFiberTM) for 6 weeks on fecal SCFA levels, gut microbial composition and immune cell composition in minimal stage II A melanoma patients following surgical treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-26
• Status Verified: 2025-09
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2026-03-25
• Study Completion: 2027-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels	6 weeks	Effect of a high fiber prebiotic vegetable (WholeFiber) for 6 weeks on fecal SCFA levels in intermediate to high-risk cutaneous melanoma patients, with no concurrent adjuvant treatment. HPLC ion chromatography system (Metrohm AG, Herisau, Switzerland) will be used to determine the levels of SCFA. The concentrations of SCFA; butyrate, propionate, and acetate will be measured with a conductivity detector. SCFA will be measured at baseline, halfway intervention and after 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Discovering the gut microbial composition changes	6 weeks	Discovering the gut microbial composition changes measured in intermediate to high-risk cutaneous melanoma patients with no concurrent adjuvant treatment, after using WholeFiber for 6 weeks. This analysis will be based on whole genome sequencing of fecal samples performed at the UMCG according to standardized protocol.
Exploring the effect of WholeFiber use	6 weeks	Exploring the effect of WholeFiber use for 6 weeks on immune functioning, stool patterns, fecal calprotectin levels and side effects in this patient group. Peripheral blood mononuclear cells (PBMCs) and bloodplasma will be isolated to determine immune cell composition before and after the intervention period. Fecal calprotectin will be determined using the respective ELISA kit (Thermo Fisher Scientific). Calprotectin is released when neutrophils enter the gut wall and are activated during the inflammatory process. Lastly, eating patterns, fiber intake before the interventional period, stool patterns and side effects will be identified using the Food Frequency Questionnaire, Bristol Stool Scale, Gastrointestinal Symptoms Rating Scale and Health Related Quality of Life questionnaires.

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Provincie Groningen, Netherlands