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

NCT07206017 | Recruiting

• 1 other identifier: 19789
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma, Stage II

Outcome Measures

Primary Outcomes (1)

• Effect of a high fiber prebiotic vegetable (WholeFiber) on fecal SCFA levels

  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.

  6 weeks

Secondary Outcomes (2)

• Discovering the gut microbial composition changes

  6 weeks

• Exploring the effect of WholeFiber use

  6 weeks

Study Arms (1)

prebiotic dried chicory root (WholeFiber)

EXPERIMENTAL

Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion). During 3 visits questionnaires, measurements and (blood and fecal) samples will be taken.

Other: prebiotic dried chicory root (WholeFiber)

Interventions

prebiotic dried chicory root (WholeFiber) OTHER

Supplementing with WholeFiber for 6 weeks two times a day (10 g per portion).

prebiotic dried chicory root (WholeFiber)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, Provincie Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• G. A.P. Hospers, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

G. A.P. Hospers, MD, PhD

CONTACT

+31 50 361 2821; g.a.p.hospers@umcg.nl

Emily Oosterhout, MSc

CONTACT

+31652764949; e.oosterhout@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: March 26, 2025
• Primary Completion: March 25, 2026
• Study Completion (Estimated): September 14, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

NL (1)