Evaluation of the Efficacy of Olanzapine in controlling chemotherapy-induced Nausea and Vomiting in Pediatrics
Design
A blinded randomized trial on 56 pediatric patients undergoing chemotherapy
Settings and conduct
56 patients undergoing chemotherapy and are hospitalized in Mofid Children's Hospital are randomly divided into two groups and the coded medicine package is delivered to them and finally the results will be collected.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Pediatric patients aged from 1 year to 15 years undergoing chemotherapy treatment with moderate to severe nausea inducing regimen . exclusion criteria:heart failure or heart disease associated with the risk of arrhythmia, epilepsy, kidney or liver failure, mechanical ventilation.
Intervention groups
In one group patients receive olanzapine0.1mg/kg daily and in the other group patients receive placebo once daily as oral route.
Main outcome variables
occurrence of nausea and vomiting, oral intake tolerance, weight loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009475N14
Registration date:2023-10-11, 1402/07/19
Registration timing:prospective
Last update:2023-10-11, 1402/07/19
Update count:0
Registration date
2023-10-11, 1402/07/19
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of olanzapine in treating nausea and vomiting caused by chemotherapy in children.
Public title
Olanzapine in pediatric chemotherapy induced nausea and vomiting in
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pediatric patients undergoing chemotherapy with medications inducing moderate to severe nausea
Exclusion criteria:
Heart failure or heart disease associated with the risk of Arrhythmia.
Epilepsy
Kidney failure
Liver failure
Mechanical ventilation
Age
From 1 year old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done based on the block randomization method with non-consequential codes generated by an online tool (sealedenvewlope.com)
Blinding (investigator's opinion)
Double blinded
Blinding description
The medication and placebo will be in look-alike coded packages, and the codes based on the block randomization table will be provided to the researcher by a designated person via phone. At the end of the study, after organizing the data by the same person, the statistical expert will perform the analysis. Then, the code packet will be opened, and the final results will be reported.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
institutional ethics committee for Pharmacy, Nursing and midwifery schools
Street address
2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2022-09-18, 1401/06/27
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.150
Health conditions studied
1
Description of health condition studied
Chemotherapy induced nausea and vomiting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Occurrence of nausea and vomiting
Timepoint
Daily for 7 days
Method of measurement
Questionare
Secondary outcomes
1
Description
Oral intake tolerance
Timepoint
Daily for 7 days
Method of measurement
Questionare
2
Description
Weight loss
Timepoint
Daily for 7 days
Method of measurement
Weighing
Intervention groups
1
Description
Intervention group: Olanzapine dosing 0.1 milligrams per kilogram once daily at bedtime starting with chemotherapy for 3 days
Category
Treatment - Drugs
2
Description
Control group: Placebo with the same packing once daily at bedtime starting with chemotherapy for 3 dayschemotherapy