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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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) - 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (Ketogenic diet) 		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.
  • Procedure: Biospecimen Collection
    Undergo blood and stool sample collection
    Other names:
    • Biological Sample Collection
    • Biospecimen Collected
    • Specimen Collection
  • Procedure: Computed Tomography
    Under CT
    Other names:
    • CAT
    • CAT Scan
    • Computed Axial Tomography
    • Computerized Axial Tomography
    • Computerized axial tomography (procedure)
    • Computerized Tomography
    • Computerized Tomography (CT) scan
    • CT
    • CT Scan
    • tomography
  • Other: Dietary Intervention
    Undergo ketogenic diet
    Other names:
    • Dietary Modification
    • intervention, dietary
    • Nutrition Intervention
    • Nutrition Interventions
    • Nutritional Interventions
  • Other: Educational Activity
    Receive coaching support
  • Other: Glucose Measurement
    Undergo blood glucose testing
    Other names:
    • GLUC
    • Glucose
  • Other: Ketone Measurement
    Undergo ketone measurement
    Other names:
    • Ketones
  • Other: Questionnaire Administration
    Ancillary studies
Active Comparator
Arm II (usual caare) 		Patients follow a standard of care diet on the study.
  • Other: Best Practice
    Undergo standard of care diet
    Other names:
    • standard of care
    • standard therapy

Recruiting Locations

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Marium Husain, MD, MPH
614-366-6567
Marium.Husain@osumc.edu

More Details

NCT ID
NCT06391099
Status
Recruiting
Sponsor
Ohio State University Comprehensive Cancer Center

Study Contact

The Ohio State Comprehensive Cancer Center
800-293-5066
OSUCCCClinicaltrials@osumc.edu

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] > 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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