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IRCT20180722040556N8 IRCT 2022-02-04 Esfahan University of Medical Sciences Curcumin in the prevention of cisplatin-induced acute nephrotoxicity Curcumin in the prevention of cisplatin-induced acute nephrotoxicity: a randomized,double-blind, placebo-controlled ‎clinical trial 2022-02-20 anticipated 100 Complete https://irct.ir/trial/56952 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: This study is a clinical trial. One-year sampling period on patients admitted or outpatient in hematology-oncology center of Seyyed al-Shohada hospital (affiliated to Isfahan University of Medical Sciences) or clinics affiliated to Isfahan University of Medical Sciences. This hospital is a 200 bed specialized and referral hospital for the treatment of patients with hematologic cancers or solid tumors. It is also well equipped in terms of medical staff and facilities to treat such patients, Randomization description: Sampling will be done by Blocked randomization method. Information such as the number of intervention groups (two main intervention groups, for example, A and control, for example, B), block size (multiple numbers of groups, in this study to reduce complexity, 4 will be selected). The total number of patients (sample size 60) will be entered into Internet-specific software for this calculation (for example, available at " the Create a blocked randomisation list | Sealed Envelope"). For each included patients, a specific code will be allocated in order to determine the type of included group. The predicted sample size of patients will be accomplished randomly by using this method. The main investigator will allocate the concealed code to control group or case group according to random numbers and will put them to investigators who is in charge of sampling, Blinding description: For keeping participants, investigator and health care providers blind, whole curcumin capsules will be extracted from blister and separated in considered packages by the main investigator. Finally, all drugs and placebo packages will be labelled by codes extracted from internet-based software. After completion of recruitment, each patients code were coordinated with software data and investigator or health care providers will be informed after data analyses of drugs' codes. 3 Nephrotoxicity. Intervention 1: Intervention group: Patients with malignancy who will receive cisplatin with the dose 50-100 mg/m2 will be identified and after signing the consent will be considered for intervention. Two hours before the start of cisplatin administration, the curcumin capsuls from Exir nano sina pharmaceutical company were administered to the patient in a dose of 160 mg daily (curcumin capsuls 80 mg 2 times daily). Curcumin administration continued until 5 days after cisplatin administration. All patients will be treated with a cisplatin nephropathy preventive procedure including the 0.9% sodium chloride during treatment with this drug. In the control group, the routine treatment ward protocol including 2 lit of 0.9% sodium chloride serum during cisplatin administration without placebo will be administra. Intervention 2: Control group: Patients with malignancy who will receive cisplatin will identify and after signing the consent will be considered for intervention.All patients will be treated with a cisplatin nephropathy preventive procedure including the same dose of 0.9% sodium chloride during treatment with this drug. in this group patient won't receive curcumin . Yes - There is a plan to make this available What will be shared: All collected data When: From the summer of 2021 To whom: All academic centers Conditions: All documents with citation Where to obtain: E-mail address How to obtain: After sending a request, we will call the related person and the data will be revealed in less than one week. Comments:
public Azade Moghaddas
Faculty of Pharmacy, Isfahan University of medical Sciences, Hezar jarib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 7074 moghaddas@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Azade Moghaddas
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 7074 moghaddas@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Creatinine Clearance higher than 45 mL/min based on CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) The patient who will have enough compliance and ability to take curcumin orally. All adult cancer 's patients who will receive a regimen contains cisplatin (with the usual recommended dose between 50-100 mg / m2 ) 18 years no limit Both Patients with active infection or symptoms of sepsis. Patients who have received nephrotoxic drugs such as aminoglycoside, amphotericin, vancomycin, colistin, media contrast, calcineurin inhibitors or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for the past 72 hours. Patients who are taking ifosfamide in their chemotherapy regimen Patients who are taking fluvoxamine, anagrelide, or hydroxy progesterone in their treatment regimen. Patients who may experience complications or allergic reactions to curcumin during treatment. Patients who had a history of acute kidney injury ( AKI ) before entering the study. Patients with bilirubin above 2 mg / dl or liver enzymes above 2.5 times the normal level. N17.8 Other acute kidney failure Prevention Prevention Intervention group: Patients with malignancy who will receive cisplatin with the dose 50-100 mg/m2 will be identified and after signing the consent will be considered for intervention. Two hours before the start of cisplatin administration, the curcumin capsuls from Exir nano sina pharmaceutical company were administered to the patient in a dose of 160 mg daily (curcumin capsuls 80 mg 2 times daily). Curcumin administration continued until 5 days after cisplatin administration. All patients will be treated with a cisplatin nephropathy preventive procedure including the 0.9% sodium chloride during treatment with this drug. In the control group, the routine treatment ward protocol including 2 lit of 0.9% sodium chloride serum during cisplatin administration without placebo will be administra Control group: Patients with malignancy who will receive cisplatin will identify and after signing the consent will be considered for intervention.All patients will be treated with a cisplatin nephropathy preventive procedure including the same dose of 0.9% sodium chloride during treatment with this drug. in this group patient won't receive curcumin . Incidence of cisplatin-induced renal injury according to cheng in Glomerular Filtration Rate (GFR). Timepoint: Measurement of BUN, creatinine, in urine and serum at the time of the previous day, a day and five days after treatment with Cisplatin. Method of measurement: Measurement of urine and serum values by electrolyte analyzer and fordata analysis using Statistical Package for Social Sciences (SPSS). The effect of curcumin on cisplatin-induced renal injury according to cheng in exertion rate of sodium. Timepoint: Measurement of sodium in urine and serum at the time of the previous day, a day and five days after treatment with Cisplatin. Method of measurement: Measurement of urine and serum values by electrolyte analyzer and fordata analysis using Statistical Package for Social Sciences (SPSS). The effect of curcumin on cisplatin-induced renal injury according to cheng in exertion rate of potassium. Timepoint: Measurement of potassium in urine and serum at the time of the previous day, a day and five days after treatment with Cisplatin. Method of measurement: Measurement of urine and serum values by electrolyte analyzer and fordata analysis using Statistical Package for Social Sciences (SPSS). The effect of curcumin on cisplatin-induced renal injury according to cheng in exertion rate of magnesium. Timepoint: Measurement of magnesium in urine and serum at the time of the previous day, a day and five days after treatment with Cisplatin. Method of measurement: Measurement of urine and serum values by electrolyte analyzer and fordata analysis using Statistical Package for Social Sciences (SPSS). Esfahan University of Medical Sciences Approved 2021-11-01 Ethics committee of Isfahan University of Medical Sciences Isfahan University of medical Scienices, Daneshgah street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)