Evaluation of the efficacy and safety of adding olanzapine to the standard preventive regimen for chemotherapy- induced nausea and vomiting in children of 4-18 years of age, a Randomized Clinical Trial
To assess the effects of adding olanzapine to the standard prophylactic antiemetics (ondansetrone and dexamethasone) used in children
Design
A double-blind, placebo-controlled, randomized clinical trial with parallel group
Settings and conduct
Patients hospitalized in the oncology division of Bouali Sina hospital undergoing chemotherapy with moderate to severe risk of emetogenicity will be included to receive interventions. All subjects will receive prophylactic antiemetics consist of serotonin antagonist (mainly granisetron), dexamethasone and metoclopramide . Half of them will receive daily olanzapine until the end of chemotherapy and the other half will receive placebo. Nausea and vomiting during the five days of chemotherapy and also metabolic effects including changes of fasting blood glucose and hyperlipidemia will be documented.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Age of 4 and 18 years 2- Cognitive abilities of 4 years old 3- Receive of chemotherapy with moderate to severe risk of nausea and vomiting
Exclusion criteria: 1- Brain tumor 2- Uncontrolled high blood pressure 3- Prior administration of anti-psychotics medications during 30 days before enrollment 4- History of prior malignant neuroleptic syndrome, cardiac arrhythmia or seizure 5- Hypersensitivity to olanzapine 6- Uncontrolled diabetes melitus 7- Inhibitors/Inducers of CYP1A2 enzymes
Intervention groups
First intervention group (Control): Usual prophylactic antiemetics consist of serotonin antagonist (mainly Granisetron), Dexamethasone and Metoclopramide along with placebo of Olanzapine
Second intervention group (Drug): Usual prophylactic antiemetics consist of serotonin antagonist (mainly Granisetron), Dexamethasone and Metoclopramide along with Olanzapine 0.14 mg/kg
Main outcome variables
Nausea and vomiting during 24 hours after chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090613002027N14
Registration date:2018-11-11, 1397/08/20
Registration timing:registered_while_recruiting
Last update:2018-11-11, 1397/08/20
Update count:0
Registration date
2018-11-11, 1397/08/20
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-01, 1396/10/11
Expected recruitment end date
2019-01-01, 1397/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of adding olanzapine to the standard preventive regimen for chemotherapy- induced nausea and vomiting in children of 4-18 years of age, a Randomized Clinical Trial
Public title
Olanzapine as a medication to reduce nausea and vomiting following chemotherapy in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Cognitive abilities of 4 years old age
Receiving chemotherapy medications with moderate to severe risk of emesis
Age between 4 to 18 years old
Exclusion criteria:
Brain tumor
Receive of any anti psychotics 30 days before enrollment
Inhibitors/Inducers of CYP1A2
History of neuroleptic malignant syndrome
History of seizure
Sensitivity to olanzapine
Cardiac arrhythmia
History of uncontrolled diabetes mellitus
Age
From 4 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
49
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients into two groups will be conducted according to block randomization. The number of patients in each block will be 4 including two cases of olanzapine and two cases of placebo. The patients will be randomly allocated to drug or placebo within the block. Block randomization will be used to ensure that the equal number of patients will be distributed in each group of the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo will be prepared like as the active drug and placed in the envelopes labeled by a 5-digit unique number code for each patient. The physician and patient will not be aware of the content of the envelope (e.g., drug or placebo). The study manager will keep the codes until the last of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board, Mazandaran School of Medical Sciences
Street address
Moallem Square
City
Sari
Province
Mazandaran
Postal code
4847193696
Approval date
2018-05-02, 1397/02/12
Ethics committee reference number
IR.MAZUMS.REC.1397.152
Health conditions studied
1
Description of health condition studied
Palliative care
ICD-10 code
Z51.5
ICD-10 code description
Encounter for palliative care
Primary outcomes
1
Description
Frequency of nausea in the first 5 days after chemotherapy
Timepoint
Baseline, 1, 2, 3, 4 and 5 days after intervention
Method of measurement
Interview with the patient
2
Description
Frequency of vomiting in the first 5 days after chemotherapy
Timepoint
Baseline, 1, 2, 3, 4 and 5 days after intervention
Method of measurement
Interview with the patient
Secondary outcomes
1
Description
Severity of Nausea during 5 days following chemotherapy
Timepoint
Baseline and days 1, 2, 3, 4 and 5 after intervention
Method of measurement
National Cancer Institute Common Terminology Criteria for Adverse Events version 4
2
Description
Severity of Vomiting during 5 days following chemotherapy
Timepoint
Baseline and days 1, 2, 3, 4 and 5 after intervention
Method of measurement
National Cancer Institute Common Terminology Criteria for Adverse Events version 4
3
Description
Fasting plasma glucose
Timepoint
Baseline and 5 days after intervention
Method of measurement
Laboratory Kit
4
Description
Fasting triglyceride
Timepoint
Baseline and 5 days after intervention
Method of measurement
Laboratory Kit
5
Description
Total Choleterol
Timepoint
Baseline and 5 days after intervention
Method of measurement
Laboratory Kit
6
Description
َََAspartate aminotransferase
Timepoint
Baseline and 5 days after intervention
Method of measurement
Laboratory Kit
7
Description
Alanine aminotransferase
Timepoint
Baseline and 5 days after intervention
Method of measurement
Laboratory Kit
8
Description
Prolactine
Timepoint
Baseline and 5 days after intervention
Method of measurement
Laboratory Kit
Intervention groups
1
Description
First intervention group (Control): consist of children age of 4-18 years old undergoing chemotherapy with moderate to high risk emetogenicity will receive usual prophylactic antiemetics consist of serotonin antagonist (mainly Granisetron), Dexamethasone and metoclopramide along with placebo of Olanzapine 5 mg daily until the enf of chemotherapy.
Category
Treatment - Drugs
2
Description
Second intervention group (Olanzapine) will receive Olanzapine (0.14 mg/kg) maximum 10 mg in addition to usual prophylactic antiemetics. ِOlanzapine dose will be rounded to the nearest 2.5 mg. If chemotherapy continues for more than 1 day, olanzapine will be repeated in the following days until the end of chemotherapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Sina Hospital, Sari
Full name of responsible person
Ebrahim Salehifar
Street address
Emam square, Pasdaran Boulevard
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3304 4018
Email
fkhdmona@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi (Research and Technology Deputy)
Street address
Research and Technology ِDeputy, Moallem square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4847193696
Phone
+98 11 3325 7230
Email
majsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical Pharmacy Department, Faculty of Pharmacy, KM 18 Khazar Abad Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4847193696
Phone
+98 15 1311 6546
Fax
Email
esalehifar@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical Pharmacy Department, Faculty of Pharmacy, KM 18 Khazar Abad Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4847193696
Phone
+98 15 1311 6546
Fax
Email
esalehifar@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical Pharmacy Department, Faculty of Pharmacy, KM 18 Khazar Abad Blvd, Khazar square
City
Sari
Province
Mazandaran
Postal code
4847193696
Phone
+98 15 1311 6546
Fax
Email
esalehifar@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All demographic and clinical data will be shared after masking the identification of patients.
When the data will become available and for how long
For 5 years
To whom data/document is available
Public
Under which criteria data/document could be used
Each scientific analysis will be permitted.
From where data/document is obtainable
Ebrahim Salehifar
What processes are involved for a request to access data/document
Request through Ebrahim Salehiar via an academic email that was confirmed by Research deputy of that institute