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IRCT20230107057070N1 IRCT 2023-06-21 Mazandaran University of Medical Sciences Effect of kefir on the side effects of colon cancer chemotherapy Evaluation of Kefir's Effects on Chemotherapy Complications in Colon Cancer Patients 2023-07-01 anticipated 40 Complete https://irct.ir/trial/67933 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A block classification method will be used to allocate samples into two groups. The blocking process will be done using random allocation software. Based on random numbers generated by this software, samples will be analyzed. A control group and a kefir group will be studied according to this method. 3 Colon cancer. Intervention 1: Intervention group: 20 patients with colon cancer in stages 3 and/or 4 who received injectable treatment with FOLFOX (Folinic acid, Fluorouracil, and Oxaliplatin) in 12-session chemotherapy courses. Kefir grains, industrially produced by Iran Ferment Company, Tehran, Iran, are added to milk pasteurized at 90-95°C for 10-15 minutes and cooled to 25-30°C. After the fermentation period, which lasts 24-48 hours, the seeds are separated by filtration. Kefir is stored in a container for one day, and then it is divided into bottles and stored in a refrigerator at 4 degrees Celsius. And will be used within two weeks. All kefirs prepared from the exact kefir grain are prepared under the same fermentation conditions to ensure that identical probiotics are present in the prepared kefirs. Patients will take one glass equivalent to 250 CC for six weeks at the same time as the tenth chemotherapy session. They will do this four days a week and continue until the end of the twelfth chemotherapy session. Intervention 2: Control group: 20 patients with colon cancer in stages 3 and/or 4 who are treated with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) in 12-session chemotherapy courses. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Bahareh Lashtoo Aghaee
Imam st. Behind Imam Sajad Hospital, Ramsar campus
Ramsar Iran (Islamic Republic of) 4691710001 +98 11 5509 1125 b.aghaee@hotmail.com Mazandaran University of Medical Sciences scientific Bahareh Lashtoo Aghaee
Imam st, Behind Imam Sajad Hospital, Ramsar Campus
Ramsar Iran (Islamic Republic of) 4691710001 +98 11 5509 1125 b.aghaee@hotmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients with stages 3 and/or 4 colon cancer treated with injectable FOLFOX chemotherapy for 12 sessions 18 years no limit Both Consumption of probiotic, prebiotic, or synbiotic products in the last three months Alcohol consumption Patients incapable of completing the study period Lactose malabsorption C18 Malignant neoplasm of colon Treatment - Other Treatment - Other Intervention group: 20 patients with colon cancer in stages 3 and/or 4 who received injectable treatment with FOLFOX (Folinic acid, Fluorouracil, and Oxaliplatin) in 12-session chemotherapy courses. Kefir grains, industrially produced by Iran Ferment Company, Tehran, Iran, are added to milk pasteurized at 90-95°C for 10-15 minutes and cooled to 25-30°C. After the fermentation period, which lasts 24-48 hours, the seeds are separated by filtration. Kefir is stored in a container for one day, and then it is divided into bottles and stored in a refrigerator at 4 degrees Celsius. And will be used within two weeks. All kefirs prepared from the exact kefir grain are prepared under the same fermentation conditions to ensure that identical probiotics are present in the prepared kefirs. Patients will take one glass equivalent to 250 CC for six weeks at the same time as the tenth chemotherapy session. They will do this four days a week and continue until the end of the twelfth chemotherapy session. Control group: 20 patients with colon cancer in stages 3 and/or 4 who are treated with FOLFOX (folinic acid, fluorouracil, and oxaliplatin) in 12-session chemotherapy courses. Diarrhea. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Constipation. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Xerostomia. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Sleep disorders. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Nausea. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Weight loss. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Anorexia. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Flatulence. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Dysgeusia. Timepoint: At the beginning and end of the intervention. Method of measurement: Completing the questionnaire and being evaluated in person and by phone. Mazandaran University of Medical Sciences Approved 2022-10-18 Ramsar Campus ethics commitee Imam street, behind Imam sajad hospital Ramsar Mazandaran Iran (Islamic Republic of)