Objectives:
The purpose of this study is to investigate the effect of taking Silymarin on reducing the cardiovascular and liver complications caused by the chemotherapy drugs in children with acute lymphocytic leukemia.
Metods: In a randomized clinical trial, children aged 2 to 14 years with acute lymphocytic leukemia referring to the Isfahan Seyed-al-Shohada hospital who have undergone at least 6 months of maintenance treatment and don't have a history of heart and kidney disease and do not eat any
medication except chemotherapy drugs, randomly based on a random numbers table will place in both intervention and control groups (at least 20 patient in each group). Intervention group receive Silymarin (5 milligrams per kilogram of body weight) in addition to chemotherapy drugs (included: Purinetol 75 mg and Methotrexate 20 mg per square meter body surface area) daily for 6 months and the control group receive only above chemotherapy drugs. Cardiac function by echocardiography and measuring Creatine kinase- Muscle and Brain (CK-MB) and lactate dehydrogenase enzymes and Liver complications by measuring aminotransferases and alkaline phosphatase and also coagulation tests including prothrombin time and partial thromboplastin time will be investigated at baseline, 3 and 6 months after Silymarin administration in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071935175N1
Registration date:2017-08-18, 1396/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-18, 1396/05/27
Registrant information
Name
Nahid Reisi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3235 0210
Email address
reisi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating silymarin effects on cardiac and hepatic side effects of chemotherapy drug in children with acute lymphoblastic leukemia
Public title
Protective effects of silymarin on cardiac and hepatic side effects of chemotherapy drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of ALL based on bone marrow morphology and immunophenotype; Age 2-14 years; Therapy in maintenance phase of childhood ALL (at least 6 months);
Exclusion criteria: Previous history of liver and heart disease; Take any other medicines except chemotherapy drug
Age
From 2 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave., Isfahan, IR Iran