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IRCT20200204046377N1 IRCT 2020-04-03 Shahid Beheshti University of Medical Sciences Evaluation of the efficacy of Aprepitant in vomiting of children with cancer Efficacy and safety of Aprepitant in prevention of chemotherapy induced nausea and vomiting in oncologic patients of Mofid children’s hospital 2020-02-20 anticipated 30 Complete https://irct.ir/trial/45665 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with randomization with envelopes in 4 groups A and B. In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping. 3 Malignant cancer. Intervention 1: Intervention group:We treat patients with 3 milligram in kilogram(maximum 120 milligram) Aprepitant and 0/15 milligram in kilogram ondansetron on the first day 5 minutes before chemotherapy and they received 2 milligram in kilogram (80 milligram) Aprepitant in the next 2 days. Intervention 2: Control group: The control group will receive placebo of the same form and the same amount of Aprepitant. Yes - There is a plan to make this available What will be shared: When we publish article in journal When: After the article is published To whom: Researcher in university Conditions: If there are additional questions Where to obtain: Dr Fatemeh Malek How to obtain: They have to write letters to the professors and the university Comments:
public Fatemeh Malek
Mofid children hospital, Shariati Av
Tehran Iran (Islamic Republic of) 15468-15514 +98 21 2290 5638 fmalek7721@gmail.com Shahid Beheshti University of Medical Sciences scientific Fatemeh Malek
Mofid children hospital, Shariati Av
Tehran Iran (Islamic Republic of) 15468-15514 +98 21 2290 5638 fmalek7721@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) age between 6 month to 17 years Proven malignancy Chemotherapy regimen with moderate to severe nausea Lack of nausea and vomiting 24 hours before starting chemotherapy Lack of known long QT syndrome Lack of abdominal and pelvic radiation therapy over the past week No active infection or any uncontrolled disease associated with malignancy Absence of corticosteroids starting 72 hours prior to chemotherapy for any reason Lack of Benzodiazepine or opioid for 48 hours 6 months 17 years Both Sensitivity to the drugs used Dissatisfaction D70.1 Agranulocytosis secondary to cancer chemotherapy Treatment - Drugs Treatment - Drugs Intervention group:We treat patients with 3 milligram in kilogram(maximum 120 milligram) Aprepitant and 0/15 milligram in kilogram ondansetron on the first day 5 minutes before chemotherapy and they received 2 milligram in kilogram (80 milligram) Aprepitant in the next 2 days Control group: The control group will receive placebo of the same form and the same amount of Aprepitant. Nausea and vomiting. Timepoint: After the intervention for two days. Method of measurement: Appendix link table. Shahid Beheshti University of Medical Sciences Approved 2019-05-30 Institute of Child Health-Shahid Beheshti University of Medical Sciences Unit 42,Block 5,Negin complex,North Haji Pour Amir Ave,Sazmane Ab Blvd,Sheykh Fazlolah Freeway Tehran Tehran Iran (Islamic Republic of)