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Cardioeffects of deferoxamine in acute and delayed anthracyclins cardiotoxicities

Protocol summary

Summary
1- Objectives, to evaluate the efficacy of Deferoxamine in prevention of acute and delayed doxorubicin-induced cardio toxicity. 2- Design, the study is designed as a phase 3, open label, single center, and two arms clinical trial study. Sixty patients who eligible for inclusion criteria will be enrolled in the study. They will be divided into three groups with block randomization. 3- Setting and conduct, all stages of the project explain for each patient, and then if they want to enter the project inform consent would be obtained. The patients will be treated by different doses of Deferoxamine during chemotherapy. 4- Participants including major eligibility criteria, new pediatric cancer patients who are going to receive Anthracyclin drugs as part of their chemotherapy regimen. 5- Intervention, 10 to 20 mg/kg/day and 50 mg/kg/day dose regimen of Deferoxamine in two intervention groups, respectively. One group as control will receive no treatment. 6- Main outcome measures (variables), include assessing Troponin I, NT-proBNP, cardiac function with conventional and tissue doppler echocardiography.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016080615666N5
Registration date: 2016-09-06, 1395/06/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-06, 1395/06/16
Registrant information
Name
Mohammad Reza Bordbar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 3239
Email address
bordbarm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cardioeffects of deferoxamine in acute and delayed anthracyclins cardiotoxicities
Public title
deferoxamine and its cardiotoxicity effects
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: signing informed consent; male or female aged between 2 to 18 years at screening; new pediatric cancer patients who are going to receive Anthracyclin drugs as part of their chemotherapy regimen Exclusion criteria: patients below two years old; patients with previous history of treatment with any kind of chemotherapy or radiotherapy; diagnosis of congenital heart disease, preexisting heart failure and established renal disease
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
7th floor, Vice chancellery for research affairs, Shiraz University of Medical Sciences, Zand avenue, Shiaz, Iran
City
Shiraz
Postal code
Approval date
2016-03-12, 1394/12/22
Ethics committee reference number
ir.sums.med.rec.1394.83

Health conditions studied

1

Description of health condition studied
acute and chronic cardiopathy
ICD-10 code
I51.9
ICD-10 code description
Heart disease, unspecified

Primary outcomes

1

Description
cardiac Troponin-I
Timepoint
baseline, after the first dose of doxorubicin and after chemotherapy coarse
Method of measurement
hematology analysis

2

Description
NT-proBNP
Timepoint
baseline, after the first dose of doxorubicin and after chemotherapy coarse
Method of measurement
hematology analysis

3

Description
cardiac indexes
Timepoint
baseline, 3 and 12 months intervals
Method of measurement
Conventional and tissue doppler echocardiography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Deferoxamine 10 to 20 mg/kg. Frequency and route of administration is once per day continuous IV infusion over 8 hours.
Category
Treatment - Drugs

2

Description
Intervention group 2: Deferoxamine 50 mg/kg. Frequency and route of administration is once per day continuous IV infusion over 8 hours.
Category
Treatment - Drugs

3

Description
Control group: no treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Nemazee hospital, Shiaz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Dr. Mohammad Reza Bordbar
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of research, Shiaz Univeisity of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th floor, Shiraz University of Medical Sciences, Zand avenue, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Shiaz Univeisity of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Reza Bordbar
Position
Pediatric hematologist
Other areas of specialty/work
Street address
Hematology Research Center, Nemazee Hospital, Zand Street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 1563
Fax
Email
bordbarm@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Reza Bordbar
Position
Pediatric hematologist
Other areas of specialty/work
Street address
Hematology Research center, Nemaee Hospital, Zand street, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3628 1563
Fax
Email
bordbarm@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
medical school
Full name of responsible person
Fatemeh Amirmoezi
Position
general physician
Other areas of specialty/work
Street address
Nemazee Hospital, Research Tower, Hematology Research Center
City
Shiraz
Postal code
71877-63586
Phone
+98 71 3628 1563
Fax
Email
f_amirmoezi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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