1. Home
  2. Approved trials
  3. » فارسی

The safety and efficacy of Aprepitant to prevent chemotherapy-induced nausea and vomiting in children with cancer

Protocol summary

Study aim
Determination of safety and efficacy of Aprepitant in preventing chemotherapy-induced nausea and vomiting in children with cancer
Design
َA Quasi-experimental study, No randomization, No blinding, Phase 3 on 85 patients with cancer who candidate for chemotherapy , Enrolled between َMay 2020 and August 2020
Settings and conduct
A total of 85 children with cancer who are candidates for chemotherapy and referred to Aliasghar Children's Hospital receive Ondansetron thirty minutes before treatment intravenously at a dose of 0.15 mg / kg at one time. Then, in the next course of chemotherapy, the samples were taken orally 1 hour before the chemotherapy according to the patient's age for 3 days and once in each day. After the intervention, the number of vomitings and the amount of nausea are recorded based on the statements of the parents.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Parental consent , absence of nausea and vomiting for other reasons, No history of radiotherapy, No history of allergies, No history of other diseases. Non inclusion criteria: sensitivity to drugs under the study.
Intervention groups
A total of 85 children with cancer who are candidates for chemotherapy receive Ondansetron (produced by Exir Company, Iran) thirty minutes before treatment intravenously at a dose of 0.15 mg / kg at a time. Then, in the next course of chemotherapy, the samples take Aprepitant orally (produced by Abidi, Iran) 1 hour before the chemotherapy according to the patient's age, once a day for 3 days.
Main outcome variables
Rate of nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200819048455N1
Registration date: 2020-09-13, 1399/06/23
Registration timing: retrospective

Last update: 2020-09-13, 1399/06/23
Update count: 0
Registration date
2020-09-13, 1399/06/23
Registrant information
Name
Masoumeh Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
bahoush.gr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-30, 1399/03/10
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The safety and efficacy of Aprepitant to prevent chemotherapy-induced nausea and vomiting in children with cancer
Public title
The safety and efficacy of Aprepitant to the prevention of chemotherapy-induced nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parental consent Lack of nausea and vomiting for other reasons No history of radiotherapy No history of allergies No history of other disease
Exclusion criteria:
Drug sensitivity
Age
From 6 months old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 85
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences; Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-05-24, 1399/03/04
Ethics committee reference number
IR.IUMS.FMD.REC.1399.146

Health conditions studied

1

Description of health condition studied
Malignant cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms

Primary outcomes

1

Description
Nausea and vomiting
Timepoint
After the intervention for three days
Method of measurement
Parents' statements

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A total of 85 children with cancer who are candidates for chemotherapy receive Ondansetron (produced by Exir Company, Iran) thirty minutes before treatment intravenously at a dose of 0.15 mg / kg at a time. Then, in the next course of chemotherapy, the samples take Aprepitant orally (produced by Abidi, Iran) 1 hour before the chemotherapy according to the patient's age (for ages 6 months to 12 years, the first day 3 mg/kg and on the second and third days 2 mg/kg, for ages 12 years and over, on the first day one capsule (125 mg) and on the second and third days, one 80 mg capsule), once a day for 3 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Aliaghar Children's Hospital
Full name of responsible person
Gholamreza Bahoush
Street address
Aliaghar Children's Hospital; No. 193, Vahid Dastgerdy avenue, Ayatollah Modares highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
aach@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Iran University of Medical Sciences; Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masoumeh Jafari
Position
fellow
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Aliaghar Children's Hospital; No. 193, Vahid Dastgerdy avenue, Ayatollah Modares highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
dr.masoumeh.jafari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gholamreza Bahoush
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Aliaghar Children's Hospital; No. 193, Vahid Dastgerdy avenue, Ayatollah Modares highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
grbahoush1968@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Gholamreza Bahoush
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Aliaghar Children's Hospital; No. 193, Vahid Dastgerdy avenue, Ayatollah Modares highway
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Email
grbahoush1968@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...