A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases

May 27, 2025 updated by: Arezina Kasti, Attikon Hospital

A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.

The survival interval of patients with gliomas ranges between 12 to 15 months. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. Ketosis can be an effective therapy to extend the survival of patients with gliomas.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gliomas are invasive and aggressive tumors, which derive from glial or stem cells, and after neoplastic transformation, acquire glial cell characteristics. Treatment of high-grade gliomas includes measures to relieve symptoms and eliminate or control the tumor. Surgery, radiation, and chemotherapy are the most common options. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. CKD is a restrictive therapeutic diet consisting of a 4:1 ratio of fat-to-CHO and protein. Fat provides up to 90% of the caloric intake, while overall CHO intake is less than 50 g/day. CKD reducing blood glucose levels and increasing ketone body levels stimulates biochemical changes to achieve systemic ketosis. Though, evidence for CKD in clinical practice is still limited. This study focuses on the classic ketogenic diet (CKD), adjusted for each patient's energy needs by dieticians to achieve ketosis. The primary outcome is to assess the efficacy of CKD to extend the survival of patients with high-grade gliomas and brain metastases. Historical controls will be used to compare the outcome measurements.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Arezina N. Kasti, RD
  • Phone Number: +30 +306942917860
  • Email: kastiare@yahoo.gr

Study Contact Backup

  • Name: Evangelos K. Papadopoulos, MD
  • Phone Number: +30 6936251274
  • Email: neuroevan@yahoo.gr

Study Locations

  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • Attikon University General Hospital
        • Contact:
        • Contact:
    • Athens
      • Chaidari, Athens, Greece, 12461
        • Recruiting
        • Arezina Kasti
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-80
  • Karnofsky Performance Score of 50 or more.
  • Newly diagnosed, histologically confirmed glioblastoma grade 4, or secondary metastases or progression after surgical resection, radiation and chemotherapy.
  • Normal function of liver and kidneys
  • Ability to sign informed consent form

Exclusion Criteria:

  • Diabetes mellitus
  • Life expectancy >3 months
  • Inability to adhere to diet
  • Inability to give informed consent form
  • Cholecystectomy last 1 year (before the study entry)
  • Diagnosis of genetic disorder of fat metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Classic Ketogenic Diet
Patients will adhere to a classic ketogenic diet for a period of 3 months with a possible extension depending on their compliance on the diet.
Other: CKD
Patients/families will meet with the study dietician to discuss the CKD, ask questions, and plan clinic visits. Training will take place about diet, meal planning, and ketones/glucose monitoring. The dietitian will follow the patient throughout treatment. Patients will measure their urine ketosis with urine test strips and capillary ketones with blood ketone meters daily, and they will complete records from the start till the end of the study. Finally, they will meet with the dietitian at follow-up visits and on an as-needed basis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.
Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 2 years
2 years
Changes in brain tumor size
Time Frame: 2 years, Baseline, 3, 6, 12, and 24 months
MRI (Magnetic Resonance Imaging) will be used to measure changes in tumor size (cm^2)
2 years, Baseline, 3, 6, 12, and 24 months
Assessment of Quality of life using FACT-BR (version 4) survey
Time Frame: Baseline, 3, 6, 12 months
50-item FACT-Br (Functional Assessment of Cancer Therapy - Brain) is a self-report and interview when applicable questionnaire used to assess quality of life, which includes domains such as Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Brain Cancer Subscale. Each of them is rated based on the Likert scale from 1 to 5.
Baseline, 3, 6, 12 months
Functional impairment will be assessed with the Karnofsky Performance Scale
Time Frame: Baseline, 3, 6, 12 months
The scoring is assigned by a health professional based on the hierarchical scale: 100=normal, no evidence of disease, while 10=death. Intermediate or decimal scores can be assigned.
Baseline, 3, 6, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Investigators

  • Study Director: Efstathios Boviatsis, MD, University General Hospital Attikon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2022

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

September 22, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ΕΒΔ246/14-04-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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