Clinical trial of oral magnesium oxide supplementation in prevention of cisplatin-induced hypomagnesaemia in cancer patients in Rasoul Akram hospital of Tehran university of medical sciences
Hypomagnesaemia is one of the side effects of Cisplatin which is used in cancer patients who undergo treatment with regimens containing this drug. Cisplatin causes a defect in magnesium homeostasis because of its effects on tubular reabsorption of magnesium in the kidneys and tubular necrosis. Magnesium deficiency can causes some symptoms such as neurological- muscle disorders, mental disorders, electrocardiographic changes and even sudden death because of tetany or heart attack. The aim of this study is to assess the effect of magnesium oxide supplement on prevention of hypomagnesaemia in cancer patients receiving Cisplatin. In this study 80 cancer patients who are candidate for therapy with Cisplatin containing regimen in Rasoul Akram hospital will be selected. Inclusion criteria are: absence of renal disease, alcoholism and leukemia, not on diuretic, aminoglycosides, cyclosporine and amphotericin B. The only exclusion criterion is: death before end of treatment. Patients will be divided in two groups (intervention and control) randomly. Patients in intervention group will receive magnesium oxide supplement (21CENTURY magnesium oxide 250 mg tablet) according to Cisplatin dose (500 mg/day magnesium oxide for each 50/m² of Cisplatin) during interval days between chemotherapy courses. Patients in control group do not receive any supplement. Patients’ serum levels of magnesium, calcium, potassium, sodium, urea and creatinin are measured before each chemotherapy courses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112048299N1
Registration date:2012-08-13, 1391/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-13, 1391/05/23
Registrant information
Name
Masoud Vakili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8873 4239
Email address
m-vakili@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Oncopathology Research Center of Tehran University of Medical Sciences
Expected recruitment start date
2009-12-06, 1388/09/15
Expected recruitment end date
2012-03-05, 1390/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of oral magnesium oxide supplementation in prevention of cisplatin-induced hypomagnesaemia in cancer patients in Rasoul Akram hospital of Tehran university of medical sciences
Public title
Magnesium supplementation in cancer patients under cisplatin treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: cancer diagnosis, beginning chemotherapy with Cisplatin drug, absence of renal disease and alcoholism, leukemia, non-consumption of drugs such as diuretics, aminoglycosides, cyclosporine and amphotericin B
Exclusion criteria: death before end of treatment
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Oncopathology Research Center, Ethics Committee of Tehran University of Medical Sciences
Street address
Oncopathology Research Center of Tehran University of Medical Sciences, First floor, Medical College, between Sheikh Fazlolahe Noori Exp. and Chamran Exp., Hemmat Exp., Tehran
City
Tehran
Postal code
Approval date
2009-12-07, 1388/09/16
Ethics committee reference number
361/م ت
Health conditions studied
1
Description of health condition studied
Hypomagnesaemia
ICD-10 code
E83.4
ICD-10 code description
Hypomagnesaemia (Disorders of magnesium metabolism
2
Description of health condition studied
Cancer types
ICD-10 code
C00-C14, C
ICD-10 code description
Malignant neoplasms of lip, oral cavity and pharynx, Malignant neoplasms of digestive organs, Malignant neoplasms of respiratory and intrathoracic organs, Malignant neoplasms of bone and articular cartilage, Malignant neoplasms of mesothelial and soft tis
Primary outcomes
1
Description
Serum magnesium level
Timepoint
Before starting every course of chemotherapy
Method of measurement
Biochemical analysis
Secondary outcomes
1
Description
Serum Creatinin level
Timepoint
Before starting every course of chemotherapy
Method of measurement
Biochemical analysis
2
Description
Serum Urea level
Timepoint
Before starting every course of chemotherapy
Method of measurement
Biochemical analysis
3
Description
Serum Calcium level
Timepoint
Before starting every course of chemotherapy
Method of measurement
Biochemical analysis
4
Description
Serum Potassium level
Timepoint
Before starting every course of chemotherapy
Method of measurement
Biochemical analysis
5
Description
Serum Sodium level
Timepoint
Before starting every course of chemotherapy
Method of measurement
Biochemical analysis
Intervention groups
1
Description
Patients in intervention group got magnesium oxide supplement (21CENTURY magnesium oxide 250 mg tablet)* according to Cisplatin dose (for Cisplatin dose up to 50 mg/m², 500 mg/day magnesium oxide, for Cisplatin dose: 50-100 mg/m², 1000 mg/day magnesium oxide, for Cisplatin dose more than 100 mg/m², 1500 mg/day magnesium oxide) during interval days between chemotherapy courses.
* 21Century HealthCare,Inc.,USA
Category
Prevention
2
Description
Patients in control group did not get any supplement.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Vakili
Street address
Rasoul Akram Hospital of Tehran University of Medical Sciences, Niayesh St., Sattarkhan St., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oncopathology Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohsen Asadi Lari
Street address
Oncopathology Research Center of Tehran University of Medical Sciences, First floor, Medical College, between Sheikh Fazlolahe Noori Exp. and Chamran Exp., Hemmat Exp., Tehran
City
Tehran
Grant name
1519033
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oncopathology Research Center of Tehran 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
Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Zarif Yeganeh
Position
MSc of Nutrition Sciences
Other areas of specialty/work
Street address
Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences, No. 24, Parvaneh St., Yaman St., Chamran Exp., Tehran
City
Tehran
Postal code
Phone
+98 21 2243 2503
Fax
Email
m_zarifyeganeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasoul Akram Hospital of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Vakili
Position
Hematology and Oncology Specialist, MD
Other areas of specialty/work
Street address
Rasoul Akram Hospital of Tehran University of Medical Sciences, Niayesh St., Sattarkhan St., Tehran