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

NCT05564949 | Recruiting

• 1 other identifier: ΕΒΔ246/14-04-2022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Brain; Cancer

Keywords

ketogenic; diet; gliomas; metastases

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.

Secondary Outcomes (4)

• Changes in brain tumor size

  2 years, Baseline, 3, 6, 12, and 24 months

• Time to progression

  2 years

• Assessment of Quality of life using FACT-BR (version 4) survey

  Baseline, 3, 6, 12 months

• Functional impairment will be assessed with the Karnofsky Performance Scale

  Baseline, 3, 6, 12 months

Study Arms (1)

Classic Ketogenic Diet

EXPERIMENTAL

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

Interventions

CKD OTHER

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.

Classic Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (2)

Arezina Kasti

Chaïdári, Athens, 12461, Greece

RECRUITING

Attikon University General Hospital

Athens, 12462, Greece

RECRUITING

Related Publications (4)

• Thomas JG, Veznedaroglu E. Ketogenic Diet for Malignant Gliomas: a Review. Curr Nutr Rep. 2020 Sep;9(3):258-263. doi: 10.1007/s13668-020-00332-2.

  PMID: 32720120 BACKGROUND

• Sargaco B, Oliveira PA, Antunes ML, Moreira AC. Effects of the Ketogenic Diet in the Treatment of Gliomas: A Systematic Review. Nutrients. 2022 Feb 27;14(5):1007. doi: 10.3390/nu14051007.

  PMID: 35267981 BACKGROUND

• Ebrahimpour-Koujan S, Shayanfar M, Benisi-Kohansal S, Mohammad-Shirazi M, Sharifi G, Esmaillzadeh A. Adherence to low carbohydrate diet in relation to glioma: A case-control study. Clin Nutr. 2019 Dec;38(6):2690-2695. doi: 10.1016/j.clnu.2018.11.023. Epub 2018 Nov 30.

  PMID: 30551899 BACKGROUND

• Perry A, Wesseling P. Histologic classification of gliomas. Handb Clin Neurol. 2016;134:71-95. doi: 10.1016/B978-0-12-802997-8.00005-0.

  PMID: 26948349 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Glioma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Efstathios Boviatsis, MD

  UNIVERSITY GENERAL HOSPITAL ATTIKON

  STUDY DIRECTOR

Central Study Contacts

Arezina N. Kasti, RD

CONTACT

+306942917860; kastiare@yahoo.gr

Evangelos K. Papadopoulos, MD

CONTACT

6936251274; neuroevan@yahoo.gr

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: Registered Dietitian, MSc, PhDc

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 4, 2022
• Study Start: September 20, 2022
• Primary Completion: October 30, 2025
• Study Completion: February 28, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)