Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391099
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Brief Title:
Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Study of the Safety and Feasibility of a Ketogenic Dietary Intervention to Improve Response to Immunotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 05 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
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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01894 | REGISTRY | CTRP Clinical Trial Reporting Program | None |