Glioblastoma multiforme (GBM) is the most common and most aggressive malignant primary brain tumor in humans. Metabolic regimes that use ketolysis in spite of glycolysis may have an inhibitory effect on the growth of GBM cells. Therapeutic effect of Calorie-restricted ketogenic diet on animals has been ascertained. Our goal is to compare the survival and quality of life between two groups of patients. Inclusion criteria: Patient age >49 years, KPS (Karnofsky Performance Scale) >69, had to be operated for brain tumor and Pathology is primary glioblastoma multiforme, has underwent fractionated radiotherapy for his tumor and has received chemotherapy course using Temozolomide and after being treated with surgery, radiotherapy and chemotherapy tumor has recurred. Exclusion criteria includes patients whose Ketogenic diet is contraindicated for them (Pyruvate carboxylase deficiency, Porphyria and Congenital fat metabolism disorders) and those they cannot tolerate the diet. We include 20 patients in two groups, the intervention and the control group. Intervention group patients will receive the restricted ketogenic Diet. After being admitted in the hospital will receive the ketogenic diet and then be discharged. Control group will not receive the ketogenic diet. Both groups will be followed by Brain MRI and FIM every 3 months as outpatients. Quality of life and survival of both groups will be compared. Age, time recurrence, quality of life as measured by FIM, Time of ketogenic diet and survival are the main factors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204099417N1
Registration date:2012-04-27, 1391/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-27, 1391/02/08
Registrant information
Name
Ahmad Aoude
Name of organization / entity
Rasoul Azam Hospital
Country
Lebanon
Phone
00982144865961
Email address
aoude79@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-05-31, 1389/03/10
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of calorie-Restricted Ketogenic diet on GBM patient's survival and quality of life
Public title
Therapeutic effect of ketogenic diet on survival and quality of patients with Glioblastoma Multiforme
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patient age >49 years
2- KPS (Karnofsky Performance Scale) >69
3- Patient had to be operated for brain tumor and Pathology is primary glioblastoma multiforme
4- Patient has underwent fractionated radiotherapy for his tumor
5- Patient has received chemotherapy course using Temozolomide
Exclusion criteria:
1- Other diagnosis is suspected
2- Patient could not tolerated the ketogenic diet
3- Ketogenic diet is contraindicated (Pyruvate carboxylase deficiency, Porphyria and Congenital fat metabolism disorders)
4- Patient does not agreed with the regime protocol
Age
From 50 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university ethics committee
Street address
Keshavarz street, central university building, 6th floor
City
Tehran
Postal code
Approval date
2010-05-30, 1389/03/09
Ethics committee reference number
317\130\ص\89
Health conditions studied
1
Description of health condition studied
Glioblastoma multiforme
ICD-10 code
C71
ICD-10 code description
Malignant neoplasm of brain
Primary outcomes
1
Description
Patient's survival
Timepoint
Every 3 months up to death
Method of measurement
Weeks
Secondary outcomes
1
Description
Quality of Life
Timepoint
Every 3 months
Method of measurement
Assessed by FIM Form
Intervention groups
1
Description
Intervention group: is the group of patients whose will receive the restricted ketogenic diet. patients are admitted in Shariati hospital-neurosurgery ward. Medical history, physical examination, KPS (Karnofsky Performance Scale) and FIM (Functional Independence Measure) will be assessed then routine lab test are performed (CBC, Na, K, Bun, Cr, Fbs, Urine Ketone level). Restricted Ketogenic diet is loaded for them. Blood Sugar and Urine ketone will be checked on daily base for the 1st week and then weekly. After the regime has been loaded and urine Ketone becomes positive the patient will be informed to use the ketogenic diet and follow the instructions and he would be discharged. Every 3 months a Brain MRI with and without contrast and FIM will be performed for patients. Rerecords of the Urine ketone strips and BS would be controlled for being sure that the regime is effective. Tumor size will be calculated via Brain MRI. Patients will be followed up to their death. patient's Life expectancy and quality of life will be evaluated.
Restricted ketogenic diet:
• According to patient weight one of the previously designed regimes will be picked to be suitable for the patient. Regimes are designed by a Nutrition specialist and well-matched with 25Kcal/kg.
• Before the day of admission in hospital, patient should only drink water and should not eat anything since 6pm.
• In the hospital at the 1st day of ketogenic diet loading patient weight will be recorded and suitable regime will be selected. 50% of the calculated MCT oil (Medium chain triglyceride) according to the patient weight is given in 3 divided meals as Blended MCT oil-Milk, and then the patient is monitored for diarrhea and vomiting. If diarrhea or vomiting occurs the next meal should contain 10% less MCT oil until the patient feel better. Diphenhydramine may be prescribed if needed.
• 2nd day: Fasting blood sugar and urine ketone are checked. If the patient has tolerated the diet of the 1st day, he will receive 75% of the calculated MCT oil + 50% of the suitable regime in 3-4 divided meals.
• 3rd day: Fasting blood sugar and urine ketone are checked. If the patient has tolerated the diet of the 2nd day, he will receive 100% of the calculated MCT oil + the suitable regime in 5-6 divided meals.
• 4th day: Fasting blood sugar and urine ketone are checked. If the patient has tolerated the diet he will be instructed for using the regime and planned for follow up. A multi-vitamin and minerals capsule is prescribed weekly.
Category
Treatment - Drugs
2
Description
Control group contains 10 patients whose will not receive the ketogenic diet
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr. Ahmad Aoude-Neurosurgery resident
Street address
North Karegar street- Shariati hospital-Neurosurgery ward
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshavarz street, Central University building, 5th floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Seyyed Mohamad Ghodsi
Position
Neurosurgeon (Associate Professor)
Other areas of specialty/work
Street address
North Karegar street, Shariati hospital, neurosurgery ward
City
Tehran
Postal code
Phone
+98 21 8822 0040
Fax
+98 21 8822 0040
Email
ghodsism@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Seyyed Mohammad Ghodsi
Position
Neurosurgeon (Associate Professor)
Other areas of specialty/work
Street address
North Karegar street, Shariati hospital, Neurosurgery ward
City
Tehran
Postal code
Phone
+98 21 8822 0040
Fax
+98 21 8822 0040
Email
ghodsism@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Ahmad Aoude
Position
Neurosurgery resident
Other areas of specialty/work
Street address
North Kargar Street, shariati Hospital, Neurosurgery Ward
City
Tehran
Postal code
Phone
+98 21 8822 0040
Fax
+98 21 8822 0040
Email
aoude79@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)