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Adjuvant ketogenic diet and metastatic colorectal cancer

ABSTRACT: 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. Primary outcome(s): 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. Study Design: 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.

DISEASE(S): Colon Cancer,Malignant Neoplasm Of Colon

PROVIDER: 2504589 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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| 2491521 | ecrin-mdr-crc

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