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IRCT20090613002027N14 IRCT 2018-11-11 Mazandaran University of Medical Sciences Olanzapine as a medication to reduce nausea and vomiting following chemotherapy in children Evaluation of the efficacy and safety of adding olanzapine to the standard preventive regimen for chemotherapy- induced nausea and vomiting in children of 4-18 years of age, a Randomized Clinical Trial 2018-01-01 anticipated 49 Complete https://irct.ir/trial/33882 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Allocation of patients into two groups will be conducted according to block randomization. The number of patients in each block will be 4 including two cases of olanzapine and two cases of placebo. The patients will be randomly allocated to drug or placebo within the block. Block randomization will be used to ensure that the equal number of patients will be distributed in each group of the study, Blinding description: Placebo will be prepared like as the active drug and placed in the envelopes labeled by a 5-digit unique number code for each patient. The physician and patient will not be aware of the content of the envelope (e.g., drug or placebo). The study manager will keep the codes until the last of the study. 2-3 Palliative care. Intervention 1: First intervention group (Control): consist of children age of 4-18 years old undergoing chemotherapy with moderate to high risk emetogenicity will receive usual prophylactic antiemetics consist of serotonin antagonist (mainly Granisetron), Dexamethasone and metoclopramide along with placebo of Olanzapine 5 mg daily until the enf of chemotherapy. Intervention 2: Second intervention group (Olanzapine) will receive Olanzapine (0.14 mg/kg) maximum 10 mg in addition to usual prophylactic antiemetics. ِOlanzapine dose will be rounded to the nearest 2.5 mg. If chemotherapy continues for more than 1 day, olanzapine will be repeated in the following days until the end of chemotherapy. Yes - There is a plan to make this available What will be shared: All demographic and clinical data will be shared after masking the identification of patients. When: For 5 years To whom: Public Conditions: Each scientific analysis will be permitted. Where to obtain: Ebrahim Salehifar How to obtain: Request through Ebrahim Salehiar via an academic email that was confirmed by Research deputy of that institute Comments:
public Ebrahim Salehifar
Clinical Pharmacy Department, Faculty of Pharmacy, KM 18 Khazar Abad Blvd, Khazar square
Sari Iran (Islamic Republic of) 4847193696 +98 15 1311 6546 esalehifar@mazums.ac.ir Mazandaran University of Medical Sciences scientific Ebrahim Salehifar
Clinical Pharmacy Department, Faculty of Pharmacy, KM 18 Khazar Abad Blvd, Khazar square
Sari Iran (Islamic Republic of) 4847193696 +98 15 1311 6546 esalehifar@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Cognitive abilities of 4 years old age Receiving chemotherapy medications with moderate to severe risk of emesis Age between 4 to 18 years old 4 years 18 years Both Brain tumor Receive of any anti psychotics 30 days before enrollment Inhibitors/Inducers of CYP1A2 History of neuroleptic malignant syndrome History of seizure Sensitivity to olanzapine Cardiac arrhythmia History of uncontrolled diabetes mellitus Z51.5 Encounter for palliative care Treatment - Drugs Treatment - Drugs First intervention group (Control): consist of children age of 4-18 years old undergoing chemotherapy with moderate to high risk emetogenicity will receive usual prophylactic antiemetics consist of serotonin antagonist (mainly Granisetron), Dexamethasone and metoclopramide along with placebo of Olanzapine 5 mg daily until the enf of chemotherapy. Second intervention group (Olanzapine) will receive Olanzapine (0.14 mg/kg) maximum 10 mg in addition to usual prophylactic antiemetics. ِOlanzapine dose will be rounded to the nearest 2.5 mg. If chemotherapy continues for more than 1 day, olanzapine will be repeated in the following days until the end of chemotherapy. Frequency of nausea in the first 5 days after chemotherapy. Timepoint: Baseline, 1, 2, 3, 4 and 5 days after intervention. Method of measurement: Interview with the patient. Frequency of vomiting in the first 5 days after chemotherapy. Timepoint: Baseline, 1, 2, 3, 4 and 5 days after intervention. Method of measurement: Interview with the patient. Severity of Nausea during 5 days following chemotherapy. Timepoint: Baseline and days 1, 2, 3, 4 and 5 after intervention. Method of measurement: National Cancer Institute Common Terminology Criteria for Adverse Events version 4. Severity of Vomiting during 5 days following chemotherapy. Timepoint: Baseline and days 1, 2, 3, 4 and 5 after intervention. Method of measurement: National Cancer Institute Common Terminology Criteria for Adverse Events version 4. Fasting plasma glucose. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit. Fasting triglyceride. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit. Total Choleterol. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit. َََAspartate aminotransferase. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit. Alanine aminotransferase. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit. Prolactine. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit. Mazandaran University of Medical Sciences Approved 2018-05-02 Institutional Review Board, Mazandaran School of Medical Sciences Moallem Square Sari Mazandaran Iran (Islamic Republic of)