The aim of this study was to evaluate the effect of oral olanzapine on nausea and vomiting due to chemotherapy in children with malignancy.
Design
This study is phase 3 clinical trial, children with malignancy who has inclusion criteria selected on the basis of a medical approval as a study group, based on this, in this study 60 children with inclusion criteria are selected. Patients are randomized and based on blocked methods were categorized, 30 children in the intervention group and 30 children in the placebo group. During the treatment, nausea and vomiting are assessed in three periods.
Settings and conduct
This study was carried out as a clinical trial at the pediatric clinic of Amir Kabir Hospital in Arak city, also the study will be triple blinded in which patients will be blinded in study.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all children aged 5 to 15 years of age with malignancy that recently has been diagnosed with this disease and based on the assessment, diagnosis and approval of physician has indication for chemotherapy, and patients who has a RAS score more than 20 at the first day, has included in the study.
Exclusion criteria include diseases that triggers nausea and vomiting and inability to express the severity of nausea and vomiting, also patients who are not satisfied with the study or has olanzapine side effects during the study are excluded from the study.
Intervention groups
In the intervention group, olanzapine is used as an anti-nausea and vomiting drug, and in the control group, the same placebo is used. This medicine is available in 5 milligram pills at a dose of 0.1 mg / kg PO every 24 hours (based on the weight at a maximum dose of 10 mg per day). In the control group, the same placebo was used as a triple-blind.
Main outcome variables
Nausea and vomiting caused by chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150119020715N6
Registration date:2018-06-23, 1397/04/02
Registration timing:registered_while_recruiting
Last update:2018-06-23, 1397/04/02
Update count:0
Registration date
2018-06-23, 1397/04/02
Registrant information
Name
Aziz Eghbali
Name of organization / entity
دانشگاه علوم پزشکی اراک
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 5314
Email address
dr.eghbali@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Olanzapine on the Nausea and Vomiting Induced by Chemotherapy in Children with Malignancy.
Public title
The Effect of an Oral Medicine on Nausea and Vomiting Caused by Chemotherapy in Children With Cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 5 to 15 years of age who have recently diagnosed as malignancy
Indication of chemotherapy, based on assessment, diagnosis and approval by physician
On the first day of chemotherapy, they should have a RAS score more than 20.
Exclusion criteria:
Diseases that triggers the nausea and vomiting
Inability to express the severity of nausea and vomiting
Patients who has not satisfied with the study
Olanzapine drug complications
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomization we will use the block method, based on this, two lists of patients are provided and each list is placed in one of the groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patient , the statistical analyst and physician are blind for study group.
In order to blind the patient, two lists are provided and based on the number of patient admission who is pairs or single, he were take on one of these lists.
In order to blind the statistical analyst, information is generally presented in two groups, and he does not have any information about the intervention and control groups.
Also, the physician have not any information about two groups, accordingly, use for patients medication or similar placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-02-10, 1396/11/21
Ethics committee reference number
IR.ARAKMU.REC.1396.288
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Before starting chemotherapy, 24 hours after chemotherapy and 5 days after chemotherapy
Method of measurement
To evaluate the state of nausea and vomiting in patients, RAS criteria will be used to measure the state of nausea and vomiting in patients from 1 to 100.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5 mg olanzapine tablets are used at a dose of 0.1 mg / kg PO per 24 hours (based on the weight at a maximum dose of 10 mg per day).
Category
Treatment - Drugs
2
Description
Control group: Similar placebo in control group used as triple-blind
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Dr. Tahereh Bagherloo
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
taherehbagherloo08@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
taherehbagherloo08@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?