A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases
NCT ID: NCT05564949
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2022-09-20
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
Responsible Party
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Arezina Kasti
Registered Dietitian, MSc, PhDc
Principal Investigators
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Efstathios Boviatsis, MD
Role: STUDY_DIRECTOR
UNIVERSITY GENERAL HOSPITAL ATTIKON
Locations
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Arezina Kasti
Chaïdári, Athens, Greece
Attikon University General Hospital
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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ΕΒΔ246/14-04-2022
Identifier Type: -
Identifier Source: org_study_id
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