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

University Medical Center Groningen (UMCG)

Status: Enrolling

Conditions: Melanoma, Stage II

Treatments: Other: prebiotic dried chicory root (WholeFiber)

Study type: Interventional

Funder types: Other

Identifiers

NCT07206017

19789

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

prebiotic dried chicory root (WholeFiber)

Experimental group

Description:

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.

Treatment:

Other: prebiotic dried chicory root (WholeFiber)