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IRCT20190217042735N1 IRCT 2019-07-27 Zahedan University of Medical Sciences Comparison between Olanzapine- Aprepitant- Granisetron on nausea and vomiting The comparison between Olanzapine- Aprepitant- Granisetron effects on chemotherapeutic drug induced nausea and vomiting in patients 2019-07-09 anticipated 105 Complete https://irct.ir/trial/37689 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling will be randomized with the help of permutation blocks. At first, the eligible samples will enter the study in easily or accessible method, then using randomized block method, they'll enter in one of the three study groups, Blinding description: We will explain to patients that according to the use of double blind technique, the type of drug used and the group which they are placed will not be informed to them, and if they do not accept, they will not be included in the study. After treatment, patients will be monitored for nausea and vomiting on the first day and 48 to 72 hours after chemotherapy and their clinical data will be recorded. During the study and after grouping, the groups are randomly named 1, 2, and 3, and the corresponding assistant who records the patients' clinical information, as well as the patients, will not be involved in the medications used by the name of the drugs. The main researcher will not be blinded. 3 Nausea and Vomiting. Intervention 1: Intervention group: Olanzapine: 5mg Oral Olanzapine daily in 3 days. Intervention 2: Intervention group: Aprepitant: Kytril tablet 2mg+125mg oral Aprepitant on day one,80mg in second and third day. Intervention 3: Intervention group: Granisetron: 1g Granisetron ampoules daily in 3 days. 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 No more information.
public Farnoush Tajbakhsh
Medical campus, Dr Hesabi sq.
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5744 f.tajbakhsh@zaums.ac.ir Zahedan University of Medical Sciences scientific Farnoush Tajbakhsh
Medical campus, Dr Hesabi sq.
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3329 5744 f.tajbakhsh@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Informed consent Receiving chemotherapy regimens with moderate and high nausea and vomiting Serum Creatinine 2 or less AST and ALT less than 3 times of normal upper limit Absolute Neutrophil counts of more than 1500 cubic millimeters Not having another cause for nausea and vomiting, such as brain tumors and stomach cancer 18 years 65 years Both Having nausea and vomiting too much and uncontrollable Having allergies or showing other side effects of medications Pregnant and lactating women Having chronic illnesses such as: severe heart failure, uncontrolled diabetes, cardiac arrhythmia and cardiac infarction over the past 6 months Use of other interventions or confusing drugs (Quinolones, abdominal radiotherapy, other underlying conditions, etc.) Treatment with other antipsychotic drugs (Risperidone, Quetiapine, Clozapine, Phenothiazine) 30 days before entering the study Having known problem in the CNS (cerebral metastasis or seizure) or cognitive impairment Having nausea and vomiting 24 hours before treatment R11 Nausea and vomiting Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Olanzapine: 5mg Oral Olanzapine daily in 3 days Intervention group: Aprepitant: Kytril tablet 2mg+125mg oral Aprepitant on day one,80mg in second and third day Intervention group: Granisetron: 1g Granisetron ampoules daily in 3 days Nausea and vomiting. Timepoint: First day and 48 to 72 hours after chemotherapy. Method of measurement: The patients will be monitored for nausea and vomiting on the first day and 48 to 72 hours after chemotherapy, and their clinical data will be recorded by the information form. Zahedan University of Medical Sciences Approved 2019-04-28 Ethics committee of Zahedan University of Medical Sciences Medical campus, Dr Hesabi sq. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)