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New treatment option for Melanoma, Stage II
Official title Explorative Study on Addition of High-fiber Dried Chicory Root in Patients With an Intermediate to High-risk Cutaneous Melanoma.
ClinicalTrials.gov ID: NCT07206017
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Being able to read and speak Dutch;
- Willing to come to the UMCG for practical reasons (visiting the study site);
You likely can't join if
- 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...
- Any clinically significant or unstable medical disorder involving the gut, including celiac disease, inflammatory bowel disease, short-bowel syndrome...
- 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;
See the full eligibility 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.
- 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 treatment study at the same time;
- Unable or unwilling to comply to study rules.
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Provincie Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Provincie Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.