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Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06466434
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

M.D. Anderson Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jennifer McQuade, MD
Principal Investigator Affiliation M.D. Anderson Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Unresectable Melanoma
Study Website: View Trial Website
Additional Details

Primary Objectives.• Evaluate the effect of dietary intervention on the abundance of Faecalibacterium in stool samples from baseline to 12 weeks.Secondary Objectives.

  • - Determine the best overall response rate (BORR) to PreFED + ICB regimens and landmark ORR at 12 weeks (intervention) and 24 weeks (maintenance) - Determine progression-free survival (PFS) and overall survival (OS) with PreFED + ICB regimens.
  • - Compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks.
  • - Determine the safety (diet-related AEs) and tolerability (GSRS-IBS) of the dietary intervention at 12 weeks and maintenance at 24 weeks.
  • - Assess the rate of immune related adverse events in patients on ICB regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks.
  • - Assess the effects of dietary intervention on systemic and tumor immunity.
  • - Assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks.
  • - Assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks.
- Assess the effects of dietary interventions on quality of life and other patient reported outcomes (PROs) at 12 weeks and maintenance at 24 weeks

Arms & Interventions

Arms

Experimental: Prebiotic food-enriched diet (PreFED)

Participants will receive prebiotic food-enriched snacks and supportive nutritional counseling to increase prebiotic foods in the diet.

Interventions

Other: - Prebiotic Food-Enriched Diet

Given by PO

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MD Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

MD Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Jennifer McQuade, MD

[email protected]

713-745-9947

Nearest Location

Site Contact

Jennifer McQuade, MD

[email protected]

713-745-9947


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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