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IRCT20120703010178N26 IRCT 2023-06-25 Shahid Beheshti University of Medical Sciences Impact of saffron tablets on Doxorubicin-induced cardiotoxicity The impact of saffron total glycoside tablets on Doxorubicin-induced cardiotoxicity in patients with breast cancer: Randomized clinical trial 2023-07-22 anticipated 188 Complete https://irct.ir/trial/70451 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible subjects will be randomly assigned to intervention or placebo groups with a ratio of 1:1. The randomization will be done by permuted block randomization method using sealedenvelope website, located at the address https://www.sealedenvelope.com, with a block size of 4. Depending on the selected sample size, patients will be randomly assigned to the intervention or placebo arm of the study, Blinding description: This investigation is a triple-blind trial. The manufacturing company will make the tablets containing the total saffron extract and a placebo pill that is identical to the tablets. The study participants, caregivers, outcome assessors, and data analysts will all remain unaware of the study groups. 3 Cardiomyopathy. Intervention 1: Intervention group: The patient will be assigned to the intervention group based on the predetermined random plan once the researcher has confirmed that the candidate satisfies all inclusion and exclusion criteria for entry into the study. Eligible patients will take an oral tablet containing 177 mg of saffron extract twice daily, for a period of three months or until the completion of chemotherapy (whichever comes first). Intervention 2: Control group: Patients in this group will receive placebo at a dose of one tablet twice a day for 3 months or the end of chemotherapy (whichever is earlier). Yes - There is a plan to make this available What will be shared: Primary and secondary outcome data after making unrecognizable will be released. When: 6 months after publishing the results of primary outcome. To whom: Any researchers will have access to the data after allowance of corresponding author. Conditions: Performing any analysis to any data resulted form this study will be allowed only with the permission of corresponding author Where to obtain: Correspondance How to obtain: After requesting for data, correspondence will check the authorization and then they will be informed about it Comments:
public Mohammad Sistanizad
Department of Clinical Pharmacy, Shahid Beheshti School of Pharmacy, after Niayesh intersection; Valiasr street
Tehran Iran (Islamic Republic of) 615314155 +98 218800087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mohammad Sistanizad
Department of Clinical Pharmacy, Shahid Beheshti School of Pharmacy, after Niayesh intersection; Valiasr street
Tehran Iran (Islamic Republic of) 615314155 +98 218800087 sistanizadm@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Female patients aged 18 to 70 years Patients with histologically or cytologically proven primary breast cancer Receiving chemotherapy with doxorubicin, without prior bilateral/unilateral thoracic radiotherapy Karnofsky score more than 60 Life expectancy more than 6 months 18 years 70 years Female Patients diagnosed with cardiomyopathy Patients receiving vitamin K antagonists or DOACs Patients with chronic kidney disease with eGFR < 30 ml/min/1.73 m2 Patients with serum potassium above 5.5 mmol/L Patients with severe liver failure (Child-Pough C) Patients who have previously received anthracycline Patients who are currently pregnant or breastfeeding Patients participating in other clinical trials I42.7 Cardiomyopathy due to drug and external agent Treatment - Drugs Placebo Intervention group: The patient will be assigned to the intervention group based on the predetermined random plan once the researcher has confirmed that the candidate satisfies all inclusion and exclusion criteria for entry into the study. Eligible patients will take an oral tablet containing 177 mg of saffron extract twice daily, for a period of three months or until the completion of chemotherapy (whichever comes first). Control group: Patients in this group will receive placebo at a dose of one tablet twice a day for 3 months or the end of chemotherapy (whichever is earlier). Incidence of heart failure in study subjects. Timepoint: At the beginning of the study and the end of chemotherapy or three months after the start of chemotherapy (whichever is earlier). Method of measurement: Based on the findings of echocardiography, including ejection fraction and Global Longitudinal Strain (GLS) of the heart, cardiac biomarkers, and ECG according to the definition of the European Heart Association in 2022. Prooxidant-Antioxidant Balance (PAB). Timepoint: At the beginning of the study and the end of chemotherapy or three months after the start of chemotherapy (whichever is earlier). Method of measurement: Laboratory kit. Drug adherence. Timepoint: Monthly. Method of measurement: Pill count. Prevention of Cardiovascular Disease Research Center Approved 2023-03-06 Ethics committee of Shahid Beheshti University of Medical Sciences Faculty of pharmacy, Niayesh and Vali-e-Asr junction Tehran Tehran Iran (Islamic Republic of)