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Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.
RECRUITINGN/ASponsored by University Medical Center Groningen
Actively Recruiting
PhaseN/A
SponsorUniversity Medical Center Groningen
Started2025-03-26
Est. completion2026-03-25
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07206017
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
CancerMelanoma, Stage II
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Actively Recruiting
PhaseN/A
SponsorUniversity Medical Center Groningen
Started2025-03-26
Est. completion2026-03-25
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07206017