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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • prebiotic dried chicory root (WholeFiber)

Treatment groups

20 Participants
are divided into 1 treatment group