Actively Recruiting
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Led by M.D. Anderson Cancer Center · Updated on 2026-03-24
75
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn about the possible effects of a prebiotic food-enriched diet (PreFED) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (ICB) therapy.
CONDITIONS
Official Title
Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6518 years old
- English-speaking
- Body mass index (BMI) between 18.5 and 45 kg/m2
- ECOG performance status of 0 or 1
- Histologically confirmed stage III/IV unresectable cutaneous, uveal, acral, or mucosal melanoma, including asymptomatic brain metastases
- Planned start of first-line standard-of-care immune checkpoint blockade therapy
- Prior targeted or ICB therapy in adjuvant setting allowed
- Willingness to return to MD Anderson for restaging and follow-up
- Measurable disease per RECIST 1.1 or RANO criteria or among up to 10 patients without measurable disease
- Women of childbearing potential must have negative urine pregnancy test within 1 week before dietary intervention
- Willingness to eat provided foods with some tailoring
- Willingness to comply with visits, blood draws, and stool sample collection
You will not qualify if you...
- Prior immune checkpoint blockade treatment in metastatic setting
- History of inflammatory bowel disease, total colectomy, or bariatric surgery
- Current use of steroids over prednisone 10 mg/day or equivalent
- Medical contraindications to the diet as determined by physician
- Major dietary restrictions such as relevant food allergies, celiac disease, vegan, ketogenic, or extended fasting diets
- Insulin-dependent diabetes or need for bile acid sequestrants
- Unable or unwilling to participate in study procedures
- Recent use of IV antibiotics within 1 month or oral antibiotics within 2 weeks
- Regular use of prebiotics, fiber, or probiotics supplements unwilling to stop for study
- Current smoker, heavy drinker (>14 drinks/week), or illicit drug user
- Currently pregnant, planning pregnancy, or breastfeeding
- Concurrent cancer requiring systemic therapy other than hormonal therapy
- Cognitive impairment preventing informed consent or participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Erez Baruch, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here