Phase I Study of the Safety and Feasibility of a Ketogenic Dietary Intervention to Improve Response to Immunotherapy
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.
Description
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: P…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males and females, age \>= 18 years * Clinical site A will include patients with confirmed diagnosis of metastatic melanoma (including those with brain metastases) receiving first line treatment with combination nivolumab and ipilimumab or single agent ipilimumab, nivolumab, pembrolizumab * Clinical site B will include patients with confirmed diagnosis of metastatic renal cell carcinoma (RCC) (including those with brain metastases) receiving first line treatment with combination nivolumab and ipilimumab or single agent PD-1 inhibitor (e.g., nivolumab, pembrolizumab) * Sc…
Interventions
- OtherBest Practice
Undergo standard of care diet
- ProcedureBiospecimen Collection
Undergo blood and stool sample collection
- ProcedureComputed Tomography
Under CT
- OtherDietary Intervention
Undergo ketogenic diet
- OtherEducational Activity
Receive coaching support
- OtherGlucose Measurement
Undergo blood glucose testing
- OtherKetone Measurement
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio