Clinical trial NCT05564949: A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases
Official title: A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain
Cancer
Keywords: ketogenic
diet
gliomas
metastases
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.
Secondary outcomes:
measure: Changes in brain tumor size
timeFrame: 2 years, Baseline, 3, 6, 12, and 24 months
measure: Time to progression
timeFrame: 2 years
measure: Assessment of Quality of life using FACT-BR (version 4) survey
timeFrame: Baseline, 3, 6, 12 months
measure: Functional impairment will be assessed with the Karnofsky Performance Scale
timeFrame: Baseline, 3, 6, 12 months
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: Arezina Kasti
state: Athens
city: Athens
country: Greece
facility: Attikon University General Hospital
Study officials:
affiliation: UNIVERSITY GENERAL HOSPITAL ATTIKON
name: Efstathios Boviatsis, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.