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Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278249
Recruitment Status : Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Rekha Chaudhary, University of Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioblastoma Other: Modified Atkins Ketogenic Diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified Atkins Ketogenic Diet
Modified Atkins Ketogenic Diet in combination with Temodar and Radiation
 Other: Modified Atkins Ketogenic Diet
Less than 20 grams of carbohydrates per day


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of inducing ketosis [ Time Frame: 6 weeks ]
    Ketosis measured by serum beta-hydroxybuterate


Secondary Outcome Measures :
  1. Assessment of progression free survival [ Time Frame: 6 months ]
  2. Assessment of survival [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278249


Locations
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United States, Ohio
UC Health
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Rekha Chaudhary, MD University of Cincinnati
More Information
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Responsible Party: Rekha Chaudhary, Associate Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03278249    
Other Study ID Numbers: UCCI-BRAIN-16-01
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rekha Chaudhary, University of Cincinnati:
brain tumor
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue