Back to resultsFeasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
Primary Purpose
Glioblastoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Atkins Ketogenic Diet
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring brain tumor
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed primary malignant glioma, Grade III or IV
- No uncontrolled infection or other active malignancy or chronic systemic immune therapy.
- ECOG performance status < 3.
- Life expectancy > three months.
- Adequate labs
Exclusion Criteria:
- Diagnosis of genetic disorder of fat metabolism.
- Type 2 diabetes diagnosed with a hemoglobin A1C > 6.4
- Allergic to dairy or lactose intolerance
Sites / Locations
- UC Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Modified Atkins Ketogenic Diet
Arm Description
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Outcomes
Primary Outcome Measures
Assessment of inducing ketosis
Ketosis measured by serum beta-hydroxybuterate
Secondary Outcome Measures
Assessment of progression free survival
Assessment of survival
Full Information
NCT ID
NCT03278249
First Posted
September 7, 2017
Last Updated
November 15, 2021
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT03278249
Brief Title
Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
Official Title
Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to see if people can produce ketones in their blood with the modified Atkins diet. Modified Atkins diet is a diet that produces ketones in your blood by restricting carbohydrates to <20 grams per day. Ketones are substances that are produced in the blood when fat is being broken down. Ketones may help radiation work better and may starve your tumor because it is thought that some brain tumors can not use ketones to grow and can only use sugar or glucose to grow.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
brain tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Atkins Ketogenic Diet
Arm Type
Experimental
Arm Description
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
Intervention Type
Other
Intervention Name(s)
Modified Atkins Ketogenic Diet
Intervention Description
Less than 20 grams of carbohydrates per day
Primary Outcome Measure Information:
Title
Assessment of inducing ketosis
Description
Ketosis measured by serum beta-hydroxybuterate
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Assessment of progression free survival
Time Frame
6 months
Title
Assessment of survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed primary malignant glioma, Grade III or IV
No uncontrolled infection or other active malignancy or chronic systemic immune therapy.
ECOG performance status < 3.
Life expectancy > three months.
Adequate labs
Exclusion Criteria:
Diagnosis of genetic disorder of fat metabolism.
Type 2 diabetes diagnosed with a hemoglobin A1C > 6.4
Allergic to dairy or lactose intolerance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rekha Chaudhary, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
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