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OpenTrials
Completed

NCT Number: NCT03278249

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

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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Key information

Conditions

Glioblastoma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Health

Cincinnati, Ohio, 45219, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Atkins Ketogenic Diet

Other

Less than 20 grams of carbohydrates per day

Primary outcomes

  1. Number of Participants With Ketosis

    Time frame: 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 outcomes

  1. Number of Participants With Progression Free Survival

    Time frame: 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.

  2. Assessment of Survival

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Sep 11, 2017
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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