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IRCT20200408046990N11 IRCT 2022-10-08 Mashhad University of Medical Sciences Observing the effect of nanocurcumin oral product in preventing cisplatin nephrotoxicity in cancer patients Evalution of oral nano-curcumin formulation efficacy in prevention of cisplatin induced nephrotixicity in cancer patients 2020-05-21 anticipated 40 Complete https://irct.ir/trial/65192 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using Randomization.com will implemented. This method uses simple randomization models such as head or tail, using a random number table or using computer randomization methods, and for example, each client by dropping coin will include in control or intervention group. This method is very simple to implement. Patients will receive enrollment number 1 or 2, respectively, and enter one of two groups of drugs or placebo, Blinding description: Nano-curcumin and placebo soft gels packages in identical bottle will be delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and be given a bottle with A or B mark. The physician and the resident of clinical pharmacy will evaluate patients in the course of treatment. Data collection and analysis will be performed by the clinical pharmacy resident and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis. 2 Cancer. Intervention 1: Intervention group:in the intervention group, two 40mg synacorcumin capsules per day, made by Elixir Nano Sinat, are prescribed for six chemotherapy courses, and in the control group, two placebo capsules are prescribed per day, which are filled with sinacorcumin carrier and by Elixir Nano Sina factory. They are manufactured to look similar to the original drug and are prescribed for six chemotherapy courses. Intervention 2: Control group: In the placebo control group, two placebo capsules per day, which look similar to the drug capsules and contain all the ingredients in the medicine except the active ingredient, are prescribed for six chemotherapy courses. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Sare Hosseini
Imam Reza Hospital, Shariati Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3841 2081 hosseinis@mums.ac.ir Mashhad University of Medical Sciences scientific Sare Hosseini
Imam Reza Hospital, Shariati Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3841 2081 hosseinis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with cancer and candidates for chemotherapy with regimen containing cisplatin at a dose of 70mg/m2 every three weeks or 40mg/m2 weekly Patient age above 18 years and below 70 years GFR>60 ml/min At the start of chemotherapyNormal liver function Normality of patients' CBC 18 years 60 years Both Allergy to curcuminPatient dissatisfactionReduction of patient's GFR below 45ml/min during treatmentReceiving other nephrotoxic drugs such as aminoglycosides, amphotericin, vancomycin Patients with chronic heart failure EF<60%Patients with untreated hypothyroidism or hyperthyroidismPatients with active infectionReceiving anti-inflammatory and antioxidant drugs at the same timeUnfavorable health status (PS<70%) based on karnofsky index Prevention Placebo Intervention group:in the intervention group, two 40mg synacorcumin capsules per day, made by Elixir Nano Sinat, are prescribed for six chemotherapy courses, and in the control group, two placebo capsules are prescribed per day, which are filled with sinacorcumin carrier and by Elixir Nano Sina factory. They are manufactured to look similar to the original drug and are prescribed for six chemotherapy courses Control group: In the placebo control group, two placebo capsules per day, which look similar to the drug capsules and contain all the ingredients in the medicine except the active ingredient, are prescribed for six chemotherapy courses. Serum ceratinine level, BUN. Timepoint: َAt the beginning of each chemotherapy course. Method of measurement: Blood test. Mashhad University of Medical Sciences Approved 2020-04-26 Ethics committee of Mashhad University of Medical Science Qureshi Building, Daneshgah street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)