NCT07206017 Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.
| NCT ID | NCT07206017 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Melanoma, Stage II |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2026-03-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-03-26 with a primary completion date of 2026-03-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
G. A.P. Hospers, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT07206017 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanoma, Stage II. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07206017 currently recruiting?
Yes, NCT07206017 is actively recruiting participants. Contact the research team at g.a.p.hospers@umcg.nl for enrollment information.
Where is the NCT07206017 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT07206017 clinical trial?
NCT07206017 is sponsored by University Medical Center Groningen. The principal investigator is G. A.P. Hospers, MD, PhD at University Medical Center Groningen. The trial plans to enroll 20 participants.
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