Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.
Recruiting
Phase 2
Interventional Study
Melanoma (Skin) Stage IV
Melanoma (Skin Cancer)
Melanoma Metastatic
Melanoma Advanced
Melanoma
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 70 (estimated)
- Sponsor
- Radboud University Medical Center · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
* Written informed consent must be given
* A…
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