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IRCT20190305042939N2 IRCT 2022-07-14 Esfahan University of Medical Sciences Curcumin supplementation in cancer patients under cisplatin treatment Evaluation of the effects of curcumin supplementation on oxidative stress indices in patients treated with cisplatin: a double-blind, placebo-controlled randomized clinical trial 2022-07-23 anticipated 50 Complete https://irct.ir/trial/64018 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, 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 50) will be entered into Internet-specific software for this calculation. 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: In order for the patient, researcher and the intervening physician to remain blind in the intervention, all curcumin capsules are separated from the blister and the placebo is prepared in a series of pre-prepared medicine containers completely similar to the original drug form by the executor. The intervening physician, researcher, and patients are kept blind to the type of drug (main or placebo) and the type of grouping A and B (which is the main group and which group is a placebo). 3 Cancer types. 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 capsules from Exir nano sina pharmaceutical company were administered to the patient in a dose of 160 mg daily (curcumin capsules 80 mg 2 times daily). Curcumin administration continued until 5 days after cisplatin administration. Intervention 2: Control group Patients with malignancy who will receive cisplatin will identify and after signing the consent will be considered for intervention.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 2022 To whom: All academic centers Conditions: All documents with citation Where to obtain: Through the registered e-mail address (Person responsible for scientific inquiries) and the request to the responsible author, the required documents or data will be provided to the person in less than one week. 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 Mohamadhosein Araabi
Department of Clinical Biochemistry, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib St, Isfahan
Isfahan Iran (Islamic Republic of) 8174673441 +98 31 3792 7052 mh.aarabi@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Mohamadhosein Araabi
Department of Clinical Biochemistry, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Hezar jarib St, Isfahan
Isfahan Iran (Islamic Republic of) 8174673441 +98 31 3792 7052 mh.aarabi@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with malignancy who receive cisplatin for the first time in their treatment regimens GFR higher than 60 mL/min based on CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) The patient be able to receive curcumin orally 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 have a history of taking cisplatin 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 The patient's unwillingness to cooperate during the research Patients with bilirubin above 2 mg / dl or liver enzymes above 2.5 times the normal level C56, C50 Malignant neoplasm of ovary, Malignant neoplasm of breast 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 capsules from Exir nano sina pharmaceutical company were administered to the patient in a dose of 160 mg daily (curcumin capsules 80 mg 2 times daily). Curcumin administration continued until 5 days after cisplatin administration. Control group Patients with malignancy who will receive cisplatin will identify and after signing the consent will be considered for intervention.in this group patient won't receive curcumin . Total antioxidant capacity: A set of compounds that are able to protect biological systems against the harmful effects of reactive oxygen and nitrogen species . Timepoint: Baseline and End-of-trial. Method of measurement: Total antioxidant capacity testing is performed through commercially available kits and the ELISA reader. Malondialdehyde (MDA): One of the most common lipid indicators of oxidative stress. Timepoint: Baseline and End-of-trial. Method of measurement: Serum malondialdehyde levels are assessed through commercially available kits and an ELISA reader. Activity of catalase enzyme: It is an antioxidant enzyme involved in the detoxification of hydrogen peroxide (the reactive oxygen species). Timepoint: Baseline and End-of-trial. Method of measurement: Catalase activity is assessed through commercially available kits and an ELISA reader. Activity of super oxide dismutase enzyme: It is an enzyme that converts superoxide free radicals to hydrogen peroxide and oxygen molecules. Timepoint: Baseline and End-of-trial. Method of measurement: super oxide dismutase activity is assessed through commercially available kits and an ELISA reader. Expressed levels of interleukin-6 gene. Timepoint: Baseline and End-of-trial. Method of measurement: We first synthesize RNA molecules with the help of reverse transcriptase enzyme (MMLV enzyme) and convert them into complementary DNAs called cDNAs. Then, with the help of Realtime PCR, we examine the expression of the target gene. Expressed levels of NRF-2 gene. Timepoint: Baseline and End-of-trial. Method of measurement: We first synthesize RNA molecules with the help of reverse transcriptase enzyme (MMLV enzyme) and convert them into complementary DNAs called cDNAs. Then, with the help of Realtime PCR, we examine the expression of the target gene. Esfahan University of Medical Sciences Approved 2022-03-05 Ethics committee of Isfahan University of Medical Sciences Deputy of Research & Technology, Headquarters Building No. 4, Isfahan University of Medical Sciences & Health Services, Isfahan Isfehan Isfehan Iran (Islamic Republic of)