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IRCT20210919052515N2 IRCT 2021-11-09 Oroumia University of Medical Sciences Adjuvant ketogenic diet and metastatic colorectal cancer Assessment of the adjuvant ketogenic diet effect on therapeutic outcomes in metastatic colorectal cancer patients 2021-10-23 anticipated 42 Complete https://irct.ir/trial/59046 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into intervention and control groups using block randomization method. According to the total sample size (42 patients), 7 blocks of size 6 will be considered. (A: intervention group and B: control group). So that the all possible combinations of AAABBB will be listed. Then each combination will be given a number of one to seven. A number will be selected randomly for determination of one of the possible combinations. The randomization process will be continued until the last combination is enrolled. Patients will be divided into two groups according to the order of selected blocks. 3 Colon cancer. Intervention 1: Intervention group: Patients will be received the ketogenic diet for three months in addition to the standard chemotherapy protocol. The ketogenic diet is a low-carb, high-fat diet. The ratio of macronutrients in this diet: 75% fat, 15 to 20% protein, 5 to 10% carbohydrates. The nutritionist will explain to the patients about the diet, then the manuals of this diet will be provided to patients. Patients will be followed by telephone for diet compliance. Intervention 2: Control group: In the control group, only the standard chemotherapy protocol will be implemented for patients. Yes - There is a plan to make this available What will be shared: The data is probably to be shared in the Iranian ketogenic registry. When: After the publishing of article To whom: Researchers Conditions: as published article Where to obtain: Coressponding author How to obtain: If necessary through e-mail addresses of corresponding author in the published article can have access to the data. Comments:
public Dr.Naser Masoudi
Imam Khomeini hospital, Ershad Ave, Modarres Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3337 9924 dr.nasmasoudi@gmail.com Oroumia University of Medical Sciences scientific Dr. Naser Masoudi
Imam Khomeini hospital, Ershad Ave, Modarress Blvd, Urmia, Iran.
Urmia Iran (Islamic Republic of) 5715781351 +98 44 3345 9538 dr.nasmasoudi@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Patients with stage 4 of colorectal cancer Age over 18 years 18 years no limit Both Lipid metabolism disorders such as carnitine deficiency Patients with liver failure Metastasis to more than 50% in liver tissue History of gastric and pancreatic surgeries Renal cell carcinoma Type 1 diabetes C18 Malignant neoplasm of colon Treatment - Other Treatment - Other Intervention group: Patients will be received the ketogenic diet for three months in addition to the standard chemotherapy protocol. The ketogenic diet is a low-carb, high-fat diet. The ratio of macronutrients in this diet: 75% fat, 15 to 20% protein, 5 to 10% carbohydrates. The nutritionist will explain to the patients about the diet, then the manuals of this diet will be provided to patients. Patients will be followed by telephone for diet compliance. Control group: In the control group, only the standard chemotherapy protocol will be implemented for patients. Response to treatment including primary tumor and metastasis size before and after the intervention. Timepoint: Before and three months after the intervention. Method of measurement: With CT scan imaging in millimeters. Ketone body. Timepoint: Before and three months after the intervention. Method of measurement: Ketone meter in blood serum (mM/L). Carcinoembryonic antigen (CEA). Timepoint: Before and three months after the intervention. Method of measurement: ELISA test (ng/mL). Vascular endothelium growth factor expression (VEGF). Timepoint: Before and three months after the intervention. Method of measurement: Blood serum (Pg/mL). C-Reactive Protein (CRP). Timepoint: Before and three months after the intervention. Method of measurement: Blood serum (mg/L). Oroumia University of Medical Sciences Approved 2021-07-14 Ethics Committee of Urmia University of Medical Sciences Imam Khomeini Hospital, Ershad Ave, Modarres Blvd Urmia West Azarbaijan Iran (Islamic Republic of)