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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-12

Study Completion Date

2022-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Modified Atkins Ketogenic Diet

Modified Atkins Ketogenic Diet in combination with Temodar and Radiation

Group Type EXPERIMENTAL

Modified Atkins Ketogenic Diet

Intervention Type OTHER

Less than 20 grams of carbohydrates per day

Interventions

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Modified Atkins Ketogenic Diet

Less than 20 grams of carbohydrates per day

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No