Previous research has shown that a higher fiber intake may have a beneficial effect on the intestinal health and improve the effectiveness of immunotherapy, but this is not certain. The objective of this double-blinded randomized clinical trial is to analyze, whether increased dietary fiber intake by patients with metastatic melanoma will increase the relative amount of Bifidobacterium, which in turn stimulates immune cell activity and improves the response to immunotherapy.
Histologically confirmed cutaneous melanoma classified as irresectable stage III or stage IV disease
Measurable disease according to RECIST 1.1 criteria
Age ≥ 18 years
Starting standard-of-care treatment with ICI in first line
Symptomatic brain metastases
Received prior immunotherapy; previous (neo)adjuvant treatment is allowed if the last administration is at least 6 months ago
Use of systemic immunosuppressive medications
Use of laxatives up to 1 week prior to start of ICI
Radboud University Medical Center
Lead sponsor
Wageningen University and Research
Collaborator