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IRCT20171225038073N1 IRCT 2018-08-30 Tehran University of Medical Sciences Evaluation of nephroprotective effects of Melatonin Evaluation of nephroprotective effects of Melatonin in cancer patients treated with Cisplatin 2018-07-23 anticipated 50 Complete https://irct.ir/trial/31385 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: block randomization Unit of randomization: individualized Randomization by statistical software Allocation concealment :numbered drug containers, Blinding description: Researcher and data collector: blinded because the researcher is unaware of the contents of the can Patients: blinded because they are unaware of the contents of the can Health care personnel: blinded because they are unaware of the contents of the can Data analyser: unblinded Writer of the article draft: blinded. 3 Lung، head and neck، genitourinary system or gastrointestinal cancers. Intervention 1: Intervention group: Melatonin with dose of 20 mg (two Melatonin 10 mg tablets) from Best naturals company will be prescribed every night from at least 1 day before Cisplatin administration to one week period. Intervention 2: Control group: Two tablet of Placebo will be prescribed every night from at least 1 day before Cisplatin administration to one week period. Yes - There is a plan to make this available What will be shared: The data like patient lab data and effects of Melatonin and side effects of chemotherapy will be published in form of article When: At the end of study and after publication To whom: Scientific researchers Conditions: For more researches Where to obtain: Zahra Jahangard-Rafsanjani How to obtain: After acceptance by Zahra Jahangard-Rafsanjani Comments:
public Zahra Jahangard-Rafsanjani
Keshavarz Ave
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1692 zjahangard@sina.tums.ac.ir Tehran University of Medical Sciences scientific Zahra Jahangard-Rafsanjani
Keshavarz Ave
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1692 zjahangard@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) ≥ 18 years of age Cancer patients who receive Cisplatin with ≥50 mg/m2 of dose in one day and the chemotherapy courses are repeated every 3 weeks Patients who do not use other nephrotoxic chemotherapy drugs Glomerular filtration rate (GFR)>45 ml/min (modification of diet in renal disease (MDRD) formula) Patients with one of lung، head and neck، genitourinary system, gastrointestinal cancers Karnofsky status ≥ 60% Normal liver function 18 years no limit Both Kidney cancer Inability to take oral medication Heart failure Active infection The history of using other nephrotoxic drugs (e.g. Vancomycin, Aminoglycoside, Amphotericin and NSAID) within the previous 2 weeks The patients who are using angiotensin-converting-enzyme inhibitor (ACE inhibitor) & angiotensin receptor blockers (ARB) medicines C7, C8 , C07 Malignant neoplasm of parotid gland , C08 Malignant neoplasm of other and unspecified major salivary glands, C09 Malignant neoplasm of tonsil , C10 Malignant neoplasm of oropharynx, C11 Malignant neoplasm of nasopharynx, C12 Malignant neoplasm Prevention Prevention Intervention group: Melatonin with dose of 20 mg (two Melatonin 10 mg tablets) from Best naturals company will be prescribed every night from at least 1 day before Cisplatin administration to one week period. Control group: Two tablet of Placebo will be prescribed every night from at least 1 day before Cisplatin administration to one week period. Urine Neutrophil gelatinase-associated lipocalin (NGAL) level. Timepoint: Urine NGAL level measurement dose before Cisplatin administration , 6 h and 24 h after. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method. Urine Kidney Injury Molecule-1 (KIM-1) level. Timepoint: Urine KIM1 level measurement dose before Cisplatin administration , 6 h and 24 h after. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) method. Serum creatinine level. Timepoint: Serum creatinine level measurement dose before Cisplatin administration and 72 h after. Method of measurement: Jaffe method. Tehran University of Medical Sciences Approved 2018-04-23 Ethics committee of the institute of pharmaceutical sciences Tehran university of medical sciences Tehran university of medical sciences Tehran Tehran Iran (Islamic Republic of)