The efficacy and safety of Aprepitant in the prevention of chemotherapy-induced nausea and vomiting in pediatric oncology patients are useful.
Design
This double-blind and clinical trial .30 patients who are candidate for chemotherapy at Mofid Hospital in Tehran. We will divide patients in 4 groups by simple randomization. Groups are parallel.
Settings and conduct
This double-blind and clinical trial .This double-blind and clinical trial .30 patients who are candidate for chemotherapy at Mofid Hospital in Tehran.The patients are divided into 2 groups by simple randomization with envelopes.The study is double-blind.Outcome elevator and analyzer and participant are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: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
Exclusion criteria:Sensitivity to the drugs used, dissatisfaction
Intervention groups
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.
The control group will receive placebo of the same form and the same amount of Aprepitant.
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046377N1
Registration date:2020-04-03, 1399/01/15
Registration timing:registered_while_recruiting
Last update:2020-04-03, 1399/01/15
Update count:0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Parastou Mollaei Tavana
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8823 3881
Email address
dr_p1984@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Aprepitant in prevention of chemotherapy induced nausea and vomiting in oncologic patients of Mofid children’s hospital
Public title
Evaluation of the efficacy of Aprepitant in vomiting of children with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Sensitivity to the drugs used
Dissatisfaction
Age
From 6 months old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institute of Child Health-Shahid Beheshti University of Medical Sciences
Street address
Unit 42,Block 5,Negin complex,North Haji Pour Amir Ave,Sazmane Ab Blvd,Sheykh Fazlolah Freeway
City
Tehran
Province
Tehran
Postal code
1454653916
Approval date
2019-05-30, 1398/03/09
Ethics committee reference number
IR.SBMU.RICH.REC.1398.008
Health conditions studied
1
Description of health condition studied
Malignant cancer
ICD-10 code
D70.1
ICD-10 code description
Agranulocytosis secondary to cancer chemotherapy
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
After the intervention for two days
Method of measurement
Appendix link table
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
Control group: The control group will receive placebo of the same form and the same amount of Aprepitant.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric congenital hematologic disorders research Center
Full name of responsible person
Fatemeh Malek
Street address
Mofid children hospital, Shariati Av
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 3333 0006
Email
pchd@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Mofid children hospital, Shariati Av
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2290 5368
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Malek
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Mofid children hospital, Shariati Av
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2290 5638
Email
fmalek7721@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Malek
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Others
Street address
Mofid children hospital, Shariati Av
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2290 5638
Email
fmalek7721@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parastoo Mollaei Tavana
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Mofid children hospital, Shariati Av
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2226 5488
Email
dr_p1984@yahoo.com
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
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
Researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Fatemeh Malek
What processes are involved for a request to access data/document
They have to write letters to the professors and the university