Dietary Fiber to Induce Gut Microbiota-mediated Response to Immunotherapy in Melanoma.

Sponsor
Radboud University Medical Center
Study ID
NCT07686835
Phase
PHASE2
Status
Recruiting
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Conditions

  • Melanoma
  • Melanoma (Skin Cancer)
  • Melanoma (Skin) Stage IV
  • Melanoma Advanced
  • Melanoma Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dried chicory roots — DIETARY_SUPPLEMENT
    The dried chicory roots are implemented using a dosage of 22.5 gram/day resulting in 18.5 gram additional fibers a day.
  • Placebo — DIETARY_SUPPLEMENT
    The control arm will receive 12.4 grams of placebo a day, isocaloric to the intervention.

Study Details

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.

Key Dates

First listed
Jul 7, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
May 1, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fiber intervention arm
    Dried chicory roots
  • Placebo Comparator: Placebo arm
    iso-caloric placebo (rice-puffs)

Primary Outcome Measure

An increase in the relative abundance of Bifidobacterium in fecal samples. [ Time Frame: From baseline (T0) to 3-4 weeks (T1) after start ICI ]

Central Contacts

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