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Behavioural Intervention
Prebiotic food-enriched diet (PreFED) for Melanoma
Phase 2
Waitlist Available
Led By Jennifer McQuade, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
1. Age ≥ 18 years old.
2. Body mass index (BMI) 18.5-45 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Summary
To Determine the feasibility, compliance and adherence to PreFED intervention in resectable melanoma patients initiating neoadjuvant Ipi/Nivo.
Who is the study for?
This trial is for individuals with melanoma that can be surgically removed. They are looking to see if people will follow a special diet containing Prebiotic Xnack Packouts while also receiving immune checkpoint blockade therapy.
What is being tested?
The study tests whether adding a prebiotic-enriched diet (PreFED) improves the effectiveness of neoadjuvant Ipi/Nivo, an immunotherapy treatment, in patients with resectable melanoma.
What are the potential side effects?
While specific side effects aren't listed here, typical ones from immune therapies like Ipi/Nivo include fatigue, skin reactions, digestive issues, and potential autoimmune responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The completion rate, compliance and adherence.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prebiotic food-enriched diet (PreFED)Experimental Treatment1 Intervention
Participants will identified from the clinic schedules and/or referred from participant's treating oncologists.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,212 Total Patients Enrolled
105 Trials studying Melanoma
25,662 Patients Enrolled for Melanoma
Jennifer McQuade, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
135 Total Patients Enrolled
2 Trials studying Melanoma
135 Patients Enrolled for Melanoma
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