]>
IRCT201204099417N1 IRCT 2012-04-27 Vice chancellor for research, Tehran University of Medical Sciences Therapeutic effect of ketogenic diet on survival and quality of patients with Glioblastoma Multiforme Therapeutic effect of calorie-Restricted Ketogenic diet on GBM patient's survival and quality of life 2010-05-31 anticipated 20 Complete https://irct.ir/trial/9928 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Glioblastoma multiforme. Intervention 1: 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. Intervention 2: Control group contains 10 patients whose will not receive the ketogenic diet.
public Dr. Seyyed Mohamad Ghodsi
North Karegar street, Shariati hospital, neurosurgery ward
Tehran Iran (Islamic Republic of) +98 21 8822 0040 ghodsism@tums.ac.ir Tehran university of medical sciences scientific Dr. Seyyed Mohammad Ghodsi
North Karegar street, Shariati hospital, Neurosurgery ward
Tehran Iran (Islamic Republic of) +98 21 8822 0040 ghodsism@tums.ac.ir Tehran university of medical sciences Iran (Islamic Republic of) 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 50 years 149 years Both C71 Malignant neoplasm of brain Treatment - Drugs Treatment - Other 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. Control group contains 10 patients whose will not receive the ketogenic diet Patient's survival. Timepoint: Every 3 months up to death. Method of measurement: Weeks. Quality of Life. Timepoint: Every 3 months. Method of measurement: Assessed by FIM Form. Vice chancellor for research, Tehran University of Medical Sciences Approved 2010-05-30 Tehran university ethics committee Keshavarz street, central university building, 6th floor Tehran Iran (Islamic Republic of)