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

Not Applicable

• Conditions: Glioblastoma
• Interventions: Other: Modified Atkins Ketogenic Diet

• Registration Number: NCT03278249
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Study Start: 2017-10-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-24
• Primary Completion: 2021-12-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified Atkins Ketogenic Diet	Modified Atkins Ketogenic Diet	Modified Atkins Ketogenic Diet in combination with Temodar and Radiation

Primary Outcome Measures

Name	Time	Method
Number of Participants With Ketosis	6 weeks	Ketosis measured by serum beta-hydroxybuterate. Ketosis is defined as having serum beta-hydroxybuterate (BHB) at \> 0.05 mM. Participants' BHB levels were assessed at 6 weeks after starting the study. The number of participants who had BHB at \> 0.05 mM were considered to have entered into ketosis. 9 of 9 participants met this criteria.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Progression Free Survival	6 months	Progression Free Survival (PFS) is defined as the percentage of patients without progression at 6 months. Progression will be evaluated via Radiographic Assessment in Neuro-oncology (RANO) criteria: \>5 mm increase in maximal diameter, as well as ≥ 25% increase in the sum of the products of the progressing.
Assessment of Survival	2 years

Trial Locations

Locations (1)

UC Health; 🇺🇸 Cincinnati, Ohio, United States