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

NCT03278249 | Completed Results

• 1 other identifier: UCCI-BRAIN-16-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma

Keywords

brain tumor

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Ketosis

  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.

  6 weeks

Secondary Outcomes (2)

• Number of Participants With Progression Free Survival

  6 months

• Assessment of Survival

  2 years

Study Arms (1)

Modified Atkins Ketogenic Diet

EXPERIMENTAL

Modified Atkins Ketogenic Diet in combination with Temodar and Radiation

Other: Modified Atkins Ketogenic Diet

Interventions

Modified Atkins Ketogenic Diet OTHER

Less than 20 grams of carbohydrates per day

Modified Atkins Ketogenic Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of genetic disorder of fat metabolism.
• Type 2 diabetes diagnosed with a hemoglobin A1C \> 6.4
• Allergic to dairy or lactose intolerance

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

UC Health

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Rekha Chaudhary, MD, Adjunct-Associate Professor of Medicine
• Organization: University of Cincinnati Cancer Center

Rekha.chaudhary@uc.edu

513-558-2119

Study Officials

• Rekha Chaudhary, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 11, 2017
• Study Start: October 12, 2017
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)