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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05564949
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Attikon Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Efstathios Boviatsis, MD
Principal Investigator Affiliation	UNIVERSITY GENERAL HOSPITAL ATTIKON
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Greece
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain, Cancer

Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

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