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

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About this study

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.

Condition
Melanoma, Stage II
Tested
prebiotic dried chicory root (WholeFiber)
Sponsor
University Medical Center Groningen

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Study condition: Melanoma, Stage II
  • 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 10

  • 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.

Where

1 site, 1 recruiting

UMCG

Groningen, Provincie Groningen, Netherlands

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.