Trial Title:
Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer
NCT ID:
NCT06391099
Condition:
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Cutaneous Melanoma
Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
Conditions: Official terms:
Melanoma
Carcinoma, Renal Cell
Melanoma, Cutaneous Malignant
Skin Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Undergo standard of care diet
Arm group label:
Arm II (usual caare)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and stool sample collection
Arm group label:
Arm I (Ketogenic diet)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Under CT
Arm group label:
Arm I (Ketogenic diet)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Undergo ketogenic diet
Arm group label:
Arm I (Ketogenic diet)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Educational Activity
Description:
Receive coaching support
Arm group label:
Arm I (Ketogenic diet)
Intervention type:
Other
Intervention name:
Glucose Measurement
Description:
Undergo blood glucose testing
Arm group label:
Arm I (Ketogenic diet)
Other name:
GLUC
Other name:
Glucose
Intervention type:
Other
Intervention name:
Ketone Measurement
Description:
Undergo ketone measurement
Arm group label:
Arm I (Ketogenic diet)
Other name:
Ketones
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (Ketogenic diet)
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] > 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Contact:
Last name:
Marium Husain, MD, MPH
Phone:
614-366-6567
Email:
Marium.Husain@osumc.edu
Investigator:
Last name:
Marium Husain, MD, MPH
Email:
Principal Investigator
Start date:
May 31, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06391099
http://cancer.osu.edu
