RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-04

Study Completion:2029-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06466434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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.	* Uveal melanoma 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

Inclusion Criteria

Exclusion 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 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.

* Uveal melanoma 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

Contacts and Locations

Study Contact

Jennifer McQuade, MD

CONTACT

(713) 745-9947

jmcquade@mdanderson.org

Principal Investigator

Jennifer McQuade, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Jennifer McQuade, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-04

Study Completion Date2029-06-30

Study Record Updates

Study Start Date2024-09-04

Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

Unresectable Melanoma