Melanoma Skin cancer
Conditions
Interventions
WholeFiber™ fibers are a commercially available fiber product made from dried chicory roots. It has very high levels of prebiotic dietary fibers (~85%): inulin, pectin, hemi-cellulose and cellulose. F
1%), mono- and disaccharides (3%), organic acids (2%) and minerals (2%). 
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV diseaseMeasurable disease according to RECIST 1.1 criteriaAge = 18 yearsStarting standard of care treatment with ICI in first lineAble to comply with study procedures (e.g. willing to provide fecal samples)
Exclusion criteria
Exclusion criteria: Symptomatic brain metastasesReceived prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months agoUse of systemic immunosuppressive medicationsUse of laxatives up to 1 week prior to start of ICI Use of supplements that alter bowel function or gut microbiota such as fibers/prebiotics, probiotics, synbiotics, or postbiotics up to 1 month prior to start of ICIUse of antibiotics up to 1 months prior to start of ICIUse of proton pumps inhibitors (PPI’s) up to 3 months prior to start of ICIPregnant or lactatingCurrent participation in another clinical trial requiring the use of study medicationHas a known allergy to plants such as lettuce, sage, tarragon, chicory, artichoke, chamomile, daisy, or sunflower.Has a medical history of gastrointestinal resection (appendectomy is allowed)Has active inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During this study we hope to answer multiple objectives regarding microbiota composition, radiological responses and immunological responses. The primary endpoint of this study is defined as a =5% increase (e.g. from 3% to 8%) in the relative abundance of Bifidobacterium in fecal samples between baseline (T0) and follow-up (T1) and significant differences between the experimental arm and the control arm. Based on preliminary evidence and hypotheses, we anticipate a more pronounced increase in the experimental arm, suggesting a potential modulatory effect of the intervention on Bifidobacterium relative abundance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the induced changes in the entire gut microbiota composition, changes in the systemic immune cell subsets, radiological response to treatment, and survival defined as following;Study the baseline and on-treatment gut microbiota composition of patients with melanoma treated with ICI +/- additional fibers. The associated secondary endpoint is defined by microbiota profiling assessed by changes in the overall microbiota composition and relative abundance will be analyzed in fecal samples (all time points) compared to baseline (T0).Evaluate radiological response rates and survival to ICI +/- additional fibers. The associated secondary endpoint is described as response to treatment assessed by CT/PET scan per RECIST 1.1, progression-free, and overall survival (PFS and OS) defined as the time from randomization to time of disease progression or death, respectively. Evaluate the gastro-intestinal side effects of additional fiber intake. The associated secondary endpoint is defined by gastro-intestinal toxicity and adverse events (possibly) related to the additional fiber intake are scored according to NCI CTC common criteria v 5.0. | — |
Countries
Netherlands
Contacts
Public ContactK.F. Bol
Radboud Universitair Medisch Centrum
Outcome results
None listed