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

University of Cincinnati

Status: Completed

Conditions: Glioblastoma

Treatments: Other: Modified Atkins Ketogenic Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03278249

UCCI-BRAIN-16-01

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Modified Atkins Ketogenic Diet

Experimental group

Description:

Modified Atkins Ketogenic Diet in combination with Temodar and Radiation

Treatment:

Other: Modified Atkins Ketogenic Diet