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Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer
Sponsor: Ohio State University Comprehensive Cancer Center
Summary
This phase I trial studies how well a ketogenic dietary intervention works to improve response to immunotherapy in patients with melanoma and kidney cancer that has spread from where it first started (primary site) to other places in the body (metastatic). A ketogenic diet (KD) means eating fewer carbohydrates and more fats. The purpose is to use ketones (normal breakdown from fat) instead of glucose (sugar) as an energy source. Researchers want to see whether a ketogenic diet can improve tumor response in patients receiving immune checkpoint inhibitors (ICI). ICI are newer treatment options that help the immune system better fight some cancers. Following a KD may improve tumor response in patients with metastatic melanoma and metastatic kidney cancer treated with ICI.
Official title: Phase I Study of the Safety and Feasibility of a Ketogenic Dietary Intervention to Improve Response to Immunotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-11-17
Completion Date
2027-12-31
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Best Practice
Undergo standard of care diet
Biospecimen Collection
Undergo blood and stool sample collection
Computed Tomography
Under CT
Dietary Intervention
Undergo ketogenic diet
Educational Activity
Receive coaching support
Glucose Measurement
Undergo blood glucose testing
Ketone Measurement
Undergo ketone measurement
Questionnaire Administration
Ancillary studies
Locations (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States