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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564949
• Other study ID #: ???246/14-04-2022
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: January 2024
• Source: Attikon Hospital
• Contact: Arezina N. Kasti, RD
• Phone: +306942917860
• Email: kastiare[@]yahoo.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 28, 2026
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain
• Brain Neoplasms
• Cancer
• Glioma
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
Greece	Attikon University General Hospital	Athens
Greece	Arezina Kasti	Chaidari	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Participants will be followed from date of randomization until the date of death from any cause, assessed up to 36 months.
Secondary	Changes in brain tumor size	MRI (Magnetic Resonance Imaging) will be used to measure changes in tumor size (cm^2)	2 years, Baseline, 3, 6, 12, and 24 months
Secondary	Time to progression		2 years
Secondary	Assessment of Quality of life using FACT-BR (version 4) survey	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
Secondary	Functional impairment will be assessed with the Karnofsky Performance Scale	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