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Patients undergo a ketogenic dietary intervention with personalized coaching from a dietician about the KD, which includes extensive educational and ongoing support on the KD and continuous ketone monitoring by talking to a dietician directly, with the ability to text a dietician at any time and expect a response within 12 hours over 24weeks. Patients also undergo daily blood glucose and ketone monitoring, undergo CT, undergo blood sample collection and may undergo stool sample collection on the study.

Patients follow a standard of care diet on the study.

Best Practice

Undergo blood and stool sample collection

Biospecimen Collection

Computed Tomography

Dietary Intervention

Educational Activity

Glucose Measurement

Ketone Measurement

Questionnaire Administration

The Ohio State Comprehensive Cancer Center

Marium Husain, MD, MPH

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.

PRIMARY OBJECTIVE:

I. To evaluate the safety and feasibility of establishing a ketogenic dietary intervention trial with longitudinal biospecimen collection in the Ohio State University Comprehensive Cancer Center (OSUCCC) cutaneous and genitourinary oncology clinics.

EXPLORATORY OBJECTIVE:

I. To assess whether the microbiome (binary, high versus \[vs\] low diversity) mediates the relationship between time in ketosis (days with peripheral blood beta-hydroxybutyric acid \[BHB\] \> 0.5 mM) and tumor size over the course of treatment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo a ketogenic dietary intervention with personalized coaching from a dietician about the KD, which includes extensive educational and ongoing support on the KD and continuous ketone monitoring by talking to a dietician directly, with the ability to text a dietician at any time and expect a response within 12 hours over 24weeks. Patients also undergo daily blood glucose and ketone monitoring, undergo computed tomography (CT), undergo blood sample collection and may undergo stool sample collection on the study.

ARM II: Patients follow a standard of care diet on the study.

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

Phase I Study of the Safety and Feasibility of a Ketogenic Dietary Intervention to Improve Response to Immunotherapy

Will be assessed by immune-related adverse events (irAEs), serious adverse events (SAEs), Treatment Emergent Adverse Events (TEAEs), clinical laboratory, vital signs, physical examinations. Will be monitored during study visits and telephone calls using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, which also includes irAEs. Grade 3, 4 and 5 toxicities will be reported as adverse events.

Adherence will be defined as \> 80% of days in ketosis and compliant as collecting all gut microbiome specimens. Diet adherence and progress will be assessed daily using at-home whole capillary blood glucose and continuous ketone monitoring devices

Ohio State University Comprehensive Cancer Center

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer	NCT06391099	Clinical Stage ... Metastatic Cuta... Metastatic Rena... Stage IV Renal ...	Best Practice Biospecimen Col... Computed Tomogr... Dietary Interve... Educational Act... Glucose Measure... Ketone Measurem... Questionnaire A...	18 Years -	Ohio State University Comprehensive Cancer Center
Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer	NCT06391099	Clinical Stage ... Metastatic Cuta... Metastatic Rena... Stage IV Renal ...	Best Practice Biospecimen Col... Computed Tomogr... Dietary Interve... Educational Act... Glucose Measure... Ketone Measurem... Questionnaire A...	18 Years -	Ohio State University Comprehensive Cancer Center

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