Main goal: evaluation the efficacy of oral coenzyme Q10 supplement on protection of Anthracycline-induced cardiotoxicity in pediatric malignancies. Study design: randomized clinical trial, double blind with placebo.Inclusion criteria: age between 1 and 16 years old; normal kidney and liver function; malignancy and under treatment with antracyclines; LVEF deterioration between 30 and 40%. Exclusion criteria: food supplement or other dietary regimen; congenital heart disease; other systemic disease other than cancer. Patients suffering from cancer who referred to Shafa Hospital under supervision of oncologist and are under treatment with Antracyclines will be recruited in this study. Sample size in each group will be 10. All of them after LVEF reduction divide in two groups and then under the supervision of dietitian will take Coenzyme Q10 at 20 mg for about 3 months. After that electrocardiogram and echocardiography will take again for analyzing and comparison following parameters between case and control before and after trial. Left ventricular volume chamber; left ventricular end diastolic diameter; left ventricular end systolic diameter; left ventricular ejection fraction; left ventricular fraction shortening; electrocardiogram parameters including QRS voltage; QT interval; QRS interval; PQ interval; deep S wave; deep Q wave, tall R wave and cardiac rate will be evaluated and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101026390N3
Registration date:2016-10-23, 1395/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Ehsan Ghaedi
Name of organization / entity
Ahwaz Jundishapoor ,University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3285
Email address
ghaedi.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapour University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of oral coenzyme Q10 supplement on protection of Anthracycline-induced cardiotoxicity in pediatric malignancies
Public title
The Effect Coenzyme Q10 on cardiac complacation after chemotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 1 and 16 years old; normal kidney and liver function; malignancy and under treatment with antracyclines; LVEF deterioration between 30 and 40%. Exclusion criteria: food supplement or other dietary regimen; congenital heart disease; other systemic disease other than cancer.
Age
From 1 year old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jundishapour University of Medical Sciences
Street address
Ahwaz Jundishapour University of Medical Sciences, Shahre Daneshgahi
City
Ahwaz
Postal code
Approval date
2016-06-18, 1395/03/29
Ethics committee reference number
IR.AJUMS.REC.1395.197
Health conditions studied
1
Description of health condition studied
Lymphoblastic Leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukaemia
2
Description of health condition studied
Hodgkin Lymphoma
ICD-10 code
C81
ICD-10 code description
Hodgkin lymphoma
Primary outcomes
1
Description
Left Ventricular Chamber Volume
Timepoint
Before and after intervention
Method of measurement
Echocardiography
2
Description
Left Ventricular End Diastolic Diameter
Timepoint
Before and after intervention
Method of measurement
Echocardiography
3
Description
Left Ventricular End Systolic Diameter
Timepoint
Before and after intervention
Method of measurement
Echocardiography
4
Description
Left Ventricular Ejection Fraction
Timepoint
Before and after intervention
Method of measurement
Echocardiography
5
Description
Left Ventricular Fraction Shortening
Timepoint
Before and after intervention
Method of measurement
Echocardiography
6
Description
Electrocardiogram iterpretion
Timepoint
Before and after intervention
Method of measurement
Electrocardiogram
Secondary outcomes
1
Description
Weight
Timepoint
Before and after intervention
Method of measurement
Sensitive Scale
Intervention groups
1
Description
Patients Under supervision of Nutritionist, Oncologist and cardiologist for taking Coenzyme Q10 200 mg for 3 monthes will select.
Category
Treatment - Drugs
2
Description
Patients in control group will recieve placebo in the same number of intervention group for three monthes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Kaveh Jaseb Oncologist
Street address
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jundishapour University of Medical Sciences
Full name of responsible person
Sharif Makhmalzede
Street address
Ahwaz Jundishapour University of Medical Sciences, Shahre Daneshgahi
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapour University 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
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Kaveh Jaseb
Position
Pediatric Oncologist
Other areas of specialty/work
Street address
Shafa Hospital, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3374 3285
Fax
Email
k_jaseb@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hemoglubinopathy Center
Full name of responsible person
Ehsan Ghaedi
Position
Nutritionist
Other areas of specialty/work
Street address
Hemoglobinopathy Center, University of Medical Ssience, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 3374 3285
Fax
Email
en7cyrus@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Haemoglubinopathy Center
Full name of responsible person
Ehsan Ghaedi
Position
Nutritionist
Other areas of specialty/work
Street address
Haemoglubinopathy Center, Shafa Hospital
City
Ahwaz
Postal code
Phone
+98 61 3374 3285
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)