Comparison of the cardiotoxic effects of continuous infusion and bolus injection of doxorubicin in children with ALL
Design
Clinical trial with two intervention groups with parallel groups, randomized, on 60 patients. A table of random numbers was used for randomization
Settings and conduct
Place of study: Shahid Sadoughi Hospital, Yazd. How to conduct the study: Patients are divided into two completely random groups according to the randomization table. The study is a single-blind study. The researcher does not know how to assign patients to two groups.
Participants/Inclusion and exclusion criteria
Entry conditions: normal echocardiography, written consent from parents, patients under 18 years of age, and patients with ALL who are using doxorubicin in their drug regimen.
Exclusion criteria: previous history of chemotherapy or radiation therapy, diagnosis of congenital heart disease, heart failure, and kidney failure.
Intervention groups
Patients of both groups receive Adriamycin. Group A patients receive Adriamycin through bolus injection and Group B patients receive Adriamycin through continuous infusion.
Main outcome variables
Cardiotoxicity (EF)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180209038673N7
Registration date:2024-01-02, 1402/10/12
Registration timing:registered_while_recruiting
Last update:2024-01-02, 1402/10/12
Update count:0
Registration date
2024-01-02, 1402/10/12
Registrant information
Name
Robab Sheikhpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3623 5958
Email address
r.sheikhpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-20, 1402/09/29
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of bolus infusion versus continuous injection of doxorubicin in children with ALL
Public title
The effects of bolus infusion versus continuous injection of doxorubicin in children with ALL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Normal echocardiography,
Written consent from parents,
patients under 18 years of age,
patients with ALL who usd doxorubicin in their drug regimen
Exclusion criteria:
Previous history of chemotherapy or radiation therapy
Diagnosis of congenital heart disease
Diagnosis of heart failure
Diagnosis of kidney failure
Age
From 1 year old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of the the two intervention groups is done based on quadruple blocks in Excel software. In this software, the intervention groups (A, and B) are placed alternately. In the next column, there are quadruple blocks. At the end, the random digits created by the software RND0 function are placed. We then arrange the numbers based on block columns and random values.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher does not know about prescription drugs. This means that the researcher knows the two groups only as group A and group B and has no knowledge of which intervention group the patients have been placed in. In other words, the researcher does not know which intervention groups A and B have received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Medical Schoole, Shahid Sadoughi University of Medical Sciences
Street address
Schoole of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۶۰
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.126
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.00
ICD-10 code description
Acute lymphoblastic leukemia not having achieved remission
Primary outcomes
1
Description
cardiotoxicity effect
Timepoint
6 months after treatment
Method of measurement
Echocardiography
Secondary outcomes
1
Description
WBC measurement
Timepoint
6 months after therapy
Method of measurement
CBC instrument
Intervention groups
1
Description
Intervention group: Group A patients receive adriamycin through bolus injection. Before the intervention and 6 months after the intervention, the patients undergo echocardiography. The dose of Adriamycin is 40-60 mg/m2 and it is purchased from Türkiye
Category
Treatment - Drugs
2
Description
Intervention group: Group B patients receive adriamycin through continuous infusion. Before the intervention and 6 months after the intervention, the patients undergo echocardiography. The dose of Adriamycin is 40-60 mg/m2 and it is purchased from Türkiye
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of blood and Oncology, Shahid Sadoughi hospital
Full name of responsible person
Dr Elnaz Sheikhpour
Street address
Shhid Sadoughi hospital, Ebn Sin Blvd, Safaei, Yazd
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
r.sheikhpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Amin Salehi
Street address
Research Assistant, Imam Reza Building, Imam Hossein Square, Yazd,
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۱۸۴۱۱
Phone
+98 35 3628 9180
Email
Research@offices.yazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr Elnaz Sheikhpour
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahid Sadoughi hospital, Ebn Sina Blvd, Safaei, Yazd
City
Yazd
Province
Yazd
Postal code
8915887857.
Phone
+98 35 3822 4000
Email
r.sheikhpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Elnaz Sheikhpour
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahid Sadoughi hospital, Ebn Sina Blvd, Safaei, Yazd
City
Yazd
Province
Yazd
Postal code
8915887857.
Phone
+98 35 3822 4000
Email
r.sheikhpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Elnaz Sheikhpour
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahid Sadoughi hospital, Ebn Sina Blvd, Safaei, Yazd
City
یزد
Province
Yazd
Postal code
8915887857.
Phone
+98 35 3822 4000
Email
r.sheikhpour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available