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IRCT20210415050976N14 IRCT 2024-02-19 Jahrom University of Medical Sciences Investigating the role of Elanzapine in reducing nausea and vomiting caused by chemotherapy in patients undergoing chemotherapy Investigating the role of Elanzapine in reducing nausea and vomiting caused by chemotherapy in patients undergoing chemotherapy 2024-01-10 anticipated 42 Complete https://irct.ir/trial/74536 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Generation of random numbers from the table of random numbers: Considering that 42 patients are needed in this study, one number is randomly selected in the table of random numbers and the two digits to the right of it are taken into account, if these two digits are an even number, the patient is assigned to the group intervention, and if there is an individual, he will be assigned to the control group. For example, in the table of random numbers, the number 13 was chosen because 13 is an odd number, so the first sample will be assigned to the control group. In the table, random numbers move in rows from left to right, and with the above pattern, the method of assigning people to two groups is determined, Blinding description: For blinding in the present study, a double-blind method is used so that 1- the person who checks the results and 2- the person who prescribes the drugs do not know which patient received olanzapine. Blinding of the researcher and the patient will be done by placing the drug in similar packages without information about the type of drug. 1-2 Nausea and vomiting caused by chemotherapy. Intervention 1: Intervention group 1: They will receive a standard anti-nausea regimen including: 8 mg of intravenous dexamethasone, along with 1 mg of granistrone and aperitnet 125 minutes before chemotherapy on the first day. Also, in the standard regimen, Apritent 80 will be continued on the second and third day, and they will receive 5 mg of olanzapine every morning for 5 days. Intervention 2: Control group: The entire protocol of the intervention group is exactly repeated, except that instead of olanzapine, a placebo of the same form as olanzapine tablets containing starch and flour will be used. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Navid Kalani
Jahrom, Shahid Motahari Boulevard
Jahram Iran (Islamic Republic of) 7413188941 +98 71 5437 2252 k.navid@jums.ac.ir Jahrom University of Medical Sciences scientific Navid Kalani
Jahrom, Shahid Motahari Boulevard
Jahram Iran (Islamic Republic of) 7413188941 +98 71 5437 2252 k.navid@jums.ac.ir Jahrom University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age with pathologically or cytologically confirmed malignancy Patients undergoing emtogenic chemotherapy including carboplatin, irinotecan, cyclophosphamide Serum creatinine ≤2.0 mg/dl. Written informed consent 18 years no limit Both being pregnant Suffering from cognitive diseases and neurological diseases Treatment with another psychiatric medication such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone within 30 days before or during protocol treatment Simultaneous abdominal radiotherapy Simultaneous use of quinolone antibiotic treatment Chronic alcoholism Hypersensitivity to olanzapine Known heart disease R11 Nausea and vomiting Treatment - Drugs Placebo Intervention group 1: They will receive a standard anti-nausea regimen including: 8 mg of intravenous dexamethasone, along with 1 mg of granistrone and aperitnet 125 minutes before chemotherapy on the first day. Also, in the standard regimen, Apritent 80 will be continued on the second and third day, and they will receive 5 mg of olanzapine every morning for 5 days. Control group: The entire protocol of the intervention group is exactly repeated, except that instead of olanzapine, a placebo of the same form as olanzapine tablets containing starch and flour will be used. Complete response to treatment as defined by the absence of nausea and vomiting or the need to receive adjuvant medication. Timepoint: Starting on the first day of treatment with olanzapine (day-2) and daily until day 5. Method of measurement: Using the Visual Analogue Scale. Duration of nausea. Timepoint: Starting on the first day of treatment with olanzapine (day-2) and daily until day 5. Method of measurement: According to the length of time the person has been nauseous. Number of vomiting. Timepoint: Starting on the first day of treatment with olanzapine (day-2) and daily until day 5. Method of measurement: According to the number of times the person has vomited. Jahrom University of Medical Sciences Approved 2023-10-29 Ethics Committee of Jahrom University of Medical Sciences Motahari Street, Jahrom University of Medical Sciences Jahram Fars Iran (Islamic Republic of)