IRCT20100127003210N19 IRCT 2020-02-10 Shahid Beheshti University of Medical Sciences “Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Chemotherapy “ Comparison of Mirtazapine and Olanzapine on Nausea and Vomiting following Anthracycline-Cyclophosphamide Chemotherapy Regimen in Patients with Breast Cancer 2020-01-15 anticipated 54 Complete https://irct.ir/trial/44800 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple Individual Randomization with the Card in Two Groups A and B, in this Way a Number of Cards are selected as the first Intervention Group and the same Number in the second Intervention Group, then by merging the Cards together one Card is drawn and its Allocation is recorded and the Card is returned to the other Cards after it has been removed. The Cards are then re-merged and another Card is withdrawn. The Process continues until a Random Sequence Sample Size is reached, Blinding description: Double blinding will be done for the Intervention.Groups will be designated as A and B, so the Principle Investigator, Outcome Assessor and Data Analyzer will not know how Patients are assigned. 3 Patient with breast cancer. Intervention 1: Intervention group 1: Eligible patients will receive: Triple Standard of Care Regimen [Aprepitant Capsule (125 mg PO OD on day 1, 80 mg OD on days 2-3), Granisetron (1 mg IV only on day 1), Dexametason (12 mg IV only on day 1)] and Mirtazapine Tablet (15 mg PO OD on days 1-4). The first Day of Chemotherapy begins Half an Hour to an Hour before Chemotherapy. Intervention 2: Intervention group 2: Eligible Patients will receive Triple Standard of Care Regimen [Aprepitant Capsule (125 mg PO OD on Day 1, 80 mg OD on Days 2-3), Granisetron (1 mg IV only on Day 1), Dexametason (12 mg IV only on Day 1)] and Olanzapine Tablet (10mg PO OD on Days 1-4). The first Day of Chemotherapy begins Half an Hour to an Hour before Chemotherapy. In Patients at Risk of Sedation, the Dose of Olanzapine is considered to be 5 mg. No - There is not a plan to make this available Justification or reason for not sharing IPD is اطلاعات محرمانه است