The effect of magnesium on nephrotoxicity of Carboplatin
Design
Randomized, not blinded, controlled clinical trial with a parallel group design of 25 patients in each group
Settings and conduct
This study is performed as an intervention on children with malignant carboplatin who are hospitalized in Amirkabir Hospital in Arak. Patients who meet the criteria for entry into the study based on the diagnosis of an oncologist are initially given conscious consent to participate in the study. The effects of carboplatin, its renal toxicity, and the possible effect of magnesium on reducing renal toxicity to patients are then explained by the researcher (medical student) and entered into the study after ensuring complete patient satisfaction and awareness. Patients receiving carboplatin by coin toss (milk for the intervention group and line for the control group) are randomly divided into two groups receiving Mg + magnesium supplement and not receiving Mg- magnesium. In this study, patients' creatinine, GFR and BUN levels were measured before receiving carboplatin. The creatinine, GFR and BUN levels of both groups will be measured on the third day, one week after the end of chemotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children over 2 years of age with malignancy receiving Carboplatin
Exclusion criteria: Renal impairment with GFR <30, administration of platinum or other nephrotoxic drugs, antibiotic administration
Intervention groups
Control group: Patients receive placebo tablet for two weeks each day before Carboplatin therapy.
Intervention group: Patients receive magnesium oxide 250 mg tablet for two weeks each day before Carboplatin therapy.
Main outcome variables
Creatinine serum level, blood urea nitrogen and glomerular filtration rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190619043948N1
Registration date:2020-04-11, 1399/01/23
Registration timing:registered_while_recruiting
Last update:2020-04-11, 1399/01/23
Update count:0
Registration date
2020-04-11, 1399/01/23
Registrant information
Name
Marzie Alizade Hadadhania
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 7711
Email address
marzie.alizade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-06, 1398/08/15
Expected recruitment end date
2020-05-04, 1399/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Kidney-protective Effect of Magnesium Supplementation in Carboplatin-containing Chemotherapy for Pediatric Cancer
Public title
Effect of magnesium on Nephrotoxicity of Carboplatin
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children over 2 years of age with malignancy receiving Carboplatin
Exclusion criteria:
Kidney disorder with GFR under 30
Receiving other platinum drugs or other nephrotoxic drugs
Receiving antibiotics
Age
From 2 years old to 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of the study, the demographic data collection form will be completed, and if you have the conditions to enter the study of patients receiving carboplatin by coin toss (heads for the intervention group and tails for the control group) randomly, to the two groups receiving magnesium supplement Mg + And do not receive Mg-magnesium.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences