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Trial Title:
A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases
NCT ID:
NCT05564949
Condition:
Brain
Cancer
Conditions: Official terms:
Neoplasm Metastasis
Glioma
Brain Neoplasms
Conditions: Keywords:
ketogenic
diet
gliomas
metastases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
CKD
Description:
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.
Arm group label:
Classic Ketogenic Diet
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Arezina Kasti
Address:
City:
Chaidari
Zip:
12461
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Arezina N. Kasti, RD
Phone:
+306942917860
Phone ext:
+30
Email:
kastiare@yahoo.gr
Contact backup:
Last name:
Evangelos K. Papadopoulos, MD
Phone:
6936251274
Phone ext:
+30
Email:
neuroevan@yahoo.gr
Facility:
Name:
Attikon University General Hospital
Address:
City:
Athens
Zip:
12462
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Arezina N. Kasti, RD
Phone:
2105832575
Phone ext:
+30
Email:
kastiare@yahoo.gr
Contact backup:
Last name:
Evangelos K. Papadopoulos, MD
Phone:
6936251274
Phone ext:
+30
Email:
neuroevan@yahoo.gr
Start date:
September 20, 2022
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Attikon Hospital
Agency class:
Other
Source:
Attikon Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05564949
