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

NCT ID: NCT07206017

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-26
• Study Completion Date: 2027-09-14

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

prebiotic dried chicory root (WholeFiber)

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.

Group Type: EXPERIMENTAL

prebiotic dried chicory root (WholeFiber)

Intervention Type: OTHER

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

Interventions

prebiotic dried chicory root (WholeFiber)

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

G. A.P. Hospers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

UMCG

Groningen, Provincie Groningen, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

G. A.P. Hospers, MD, PhD

Role: CONTACT

g.a.p.hospers@umcg.nl

+31 50 361 2821

Emily Oosterhout, MSc

Role: CONTACT

e.oosterhout@umcg.nl

+31652764949

Facility Contacts

G. A.P. Hospers, MD, PhD

Role: primary

g.a.p.hospers@umcg.nl

+31 50 361 2821

Emily Oosterhout, MSc

Role: backup

e.oosterhout@umcg.nl

+31652764949

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19789

Identifier Type: -

Identifier Source: org_study_id