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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06391099
Other study ID # OSU-21335
Secondary ID NCI-2024-01894
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 31, 2024
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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: 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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) - Scheduled for imaging every 6 to 12 weeks for metastatic melanoma (MM) and mRCC as is standard of care per National Comprehensive Cancer Network (NCCN) guidelines - Able to read, understand, and provide written informed consent - Willing to provide stool specimen for research studies as outlined in the timeline - Willing to participate in a ketogenic diet (KD) Exclusion Criteria: - Individuals < 18 years of age - Unable or unwilling to provide consent - Patients with type 1 diabetes mellitus or type 2 diabetes using insulin - Patients who are clinically underweight (body mass index [BMI] < 18.5) at the start of treatment - Other active malignancy (other than adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or any other cancer from which the patient has been disease free >=5 years) - Currently consuming a low-carbohydrate (< 130 g/day) or ketogenic diet or done so in the last 6-months - Women who are known to be pregnant are excluded. However no additional pregnancy testing out of what would be recommended prior to initiating anti-cancer therapy will be performed solely for this study - Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Best Practice
Undergo standard of care diet
Procedure:
Biospecimen Collection
Undergo blood and stool sample collection
Computed Tomography
Under CT
Other:
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

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events 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. Up to 1 year
Primary Adherence (feasibility measure) 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 Up to 1 year
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