Prebiotic Food-enriched Diet (PreFED) to Enhance the Microbiome and Response to First-line Immunotherapy in Unresectable Melanoma

Launched by M.D. ANDERSON CANCER CENTER · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial, called PreFED, is exploring whether a special diet rich in prebiotics can help improve the gut bacteria of patients with unresectable melanoma who are starting a type of cancer treatment known as immune checkpoint blockade (ICB) therapy. The goal is to see if this diet can enhance how well the immune therapy works in fighting the cancer. The trial is currently looking for participants aged 18 and older, who are diagnosed with advanced melanoma but have not had surgery to remove it. Participants should be in good health overall, able to complete health assessments on their own, and willing to follow the diet provided.

If you join the study, you can expect to eat specific prebiotic foods tailored to your tastes, while also keeping track of your diet and any digestive symptoms you may experience. You will need to visit the clinic for check-ups and provide samples for testing. It's important to note that there are some restrictions on who can participate, such as those with certain medical conditions or dietary restrictions, so not everyone will be eligible. This trial aims to find out if dietary changes can positively impact treatment responses in melanoma patients, and your involvement could contribute to important research in this area.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years old
• • Able to self-complete study assessments monitoring diet and gastrointestinal symptom burden
• • Body mass index (BMI) 18.5-45 kg/m2
• • ECOG performance status of 0 or 1
• • Histologically confirmed stage III/IV, unresectable cutaneous, uveal, acral, or mucosal melanoma. Asymptomatic brain metastases are allowed.
• • Planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-PD1 +/- anti-CTLA4 or anti-LAG3 inhibitors) in the metastatic setting (prior ICB in adjuvant setting is allowed if last exposure ≥ 6 months prior). Prior targeted therapy is also allowed.
• • Returning to MD Anderson for restaging and follow-up (ICB treatment may occur locally)
• • WOCP must have negative UPT within 1 week of beginning dietary intervention.
• • Self-reported willingness to eat the provided foods (with some tailoring to their food preferences)
• • Self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples.
• Exclusion Criteria:
• • Previous ICB treatment in the metastatic setting
• • History of inflammatory bowel disease, total colectomy, or bariatric surgery.
• • Currently taking steroids \> Prednisone 10 mg/day or equivalent
• • Medical contraindications to the Intervention Diet as determined by the treating physician.
• • Self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting.
• • Insulin-dependent diabetes or condition requiring bile acid sequestrants
• • Unable or unwilling to undergo study procedures.
• • IV antibiotic use in the past month or oral antibiotic use in past 2 weeks.
• • Regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study.
• • Current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use.
• • Currently pregnant, planning to become pregnant, or lactating.
• • Concurrent malignancy requiring systemic therapy other than hormonal therapy.
• • Cognitively impaired adults