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IRCT201112048299N1 IRCT 2012-08-13 Oncopathology Research Center of Tehran University of Medical Sciences Magnesium supplementation in cancer patients under cisplatin treatment 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 2009-12-06 anticipated 80 Complete https://irct.ir/trial/8723 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. 2-3 Condition 1: Hypomagnesaemia. Condition 2: Cancer types. Intervention 1: 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. Intervention 2: Patients in control group did not get any supplement.
public Maryam Zarif Yeganeh
Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences, No. 24, Parvaneh St., Yaman St., Chamran Exp., Tehran
Tehran Iran (Islamic Republic of) +98 21 2243 2503 m_zarifyeganeh@yahoo.com Research Institute for Endocrine Sciences of Shahid Beheshti University of Medical Sciences scientific Dr. Masoud Vakili
Rasoul Akram Hospital of Tehran University of Medical Sciences, Niayesh St., Sattarkhan St., Tehran
Tehran Iran (Islamic Republic of) +98 21 6435 2390 m-vakili@sina.tums.ac.ir m_zarifyeganeh@yahoo.com masvak@yahoo.com Rasoul Akram Hospital of Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both E83.4 C00-C14, C Hypomagnesaemia (Disorders of magnesium metabolism 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 Prevention Prevention 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 Patients in control group did not get any supplement. Serum magnesium level. Timepoint: Before starting every course of chemotherapy. Method of measurement: Biochemical analysis. Serum Creatinin level. Timepoint: Before starting every course of chemotherapy. Method of measurement: Biochemical analysis. Serum Urea level. Timepoint: Before starting every course of chemotherapy. Method of measurement: Biochemical analysis. Serum Calcium level. Timepoint: Before starting every course of chemotherapy. Method of measurement: Biochemical analysis. Serum Potassium level. Timepoint: Before starting every course of chemotherapy. Method of measurement: Biochemical analysis. Serum Sodium level. Timepoint: Before starting every course of chemotherapy. Method of measurement: Biochemical analysis. Oncopathology Research Center of Tehran University of Medical Sciences Approved 2009-12-07 Oncopathology Research Center, Ethics Committee of Tehran University of Medical Sciences Oncopathology Research Center of Tehran University of Medical Sciences, First floor, Medical College, between Sheikh Fazlolahe Noori Exp. and Chamran Exp., Hemmat Exp., Tehran Tehran Iran (Islamic Republic of)