Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06548789
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Prebiotic Xnack Packouts — DIETARY_SUPPLEMENT
    Prebiotic snack packouts (distributed every two weeks) and diet counseling to support increased consumption of prebiotic foods which provide dietary fiber, plant-based protein and other nutrients selectively fermented by the microbiome (e.g., pulses and legumes).

Study Details

To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.

Key Dates

Start date
Sep 16, 2024
Status verified
Feb 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Prebiotic food-enriched diet (PreFED)
    Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.

Primary Outcome Measure

The completion rate, compliance and adherence. [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Erez Baruch, MD,PHD
[email protected],
713-745-5530

Find similar trials in Houston, TX

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
MD Anderson Cancer Center· Houston, TX

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