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IRCT20200408046990N17 IRCT 2024-12-22 Mashhad University of Medical Sciences Investigation of the Effect of milk thistle in preventing cardiac complications of chemotherapy Investigation of the Effect of nano-silymarin on preventing Anthracycline-Induced cardiotoxicity in patients with breast cancer 2024-12-21 anticipated 104 Complete https://irct.ir/trial/80572 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked randomization using website https://www.sealedenvelope.com With the explanation that each block has 4 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB],[BBAA],[BABA][BAAB] Code A belongs to the intervention group and code B belongs to the control group. the mentioned website selects 26 blocks from Quadruple blocks and patients will be assigned to blocks in the order of entry into the study and finally 104 patients will enter the study, Blinding description: The nano Silymarin and placebo capsule (prepared by Mashhad Pharmacy School) will be packaged in boxes with same appearance and delivered to the clinician. Patients who meet the inclusion criteria are selected by clinician to be included in the study and will receive a box filled with medication or placebo respectively. Patients will be evaluated during the treatment course by the physician. Data collection and analysis will be performed by the pharmacy student and the clinical pharmacist. All of them will be unaware patients' grouping until the end of the study and data analysis. 3 Breast cancer. Intervention 1: Intervention group: sinalive 70mg twice daily after breakfast and dinner , oral, for 4 courses of chemotherapy. Intervention 2: Control group: Placebo capsule for Sinaliv, produced by Exir Nano Sina Company that produced Sinaliv capsules, two tablet daily after breakfast and dinner, for 4 courses of chemotherapy, oral. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more data are available
public Sepideh Elyasi
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences scientific Sepideh Elyasi
Faculty of Pharmacy; Ferdowsi University; Vakilabad Boulevard
Mashhad Iran (Islamic Republic of) 17871 91886 +98 51 3180 1588 elyasis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 y Patients with breast cancer who planned for antracycline-based chemotherapy Signing of informed consent by the patient 18 years 65 years Female Presence of cardiomyopathy (dilated, restrictive or hypertro-phic) detected by baseline echocardiography History of hypersensitivity to silymarin or similar compounds Pregnancy and lactation Past medical history of coronary heart disease Moderate or severe aortic and/or mitral valve disease Prior chemotherapy or radiotherapy Alcohol abuse Patients on other cardiac medications such as angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, non-dihydropyridine calcium channel blockers, diuretics, statins or beta-blockers C50 Malignant neoplasm of breast Prevention Placebo Intervention group: sinalive 70mg twice daily after breakfast and dinner , oral, for 4 courses of chemotherapy Control group: Placebo capsule for Sinaliv, produced by Exir Nano Sina Company that produced Sinaliv capsules, two tablet daily after breakfast and dinner, for 4 courses of chemotherapy, oral Left ventricular (LV) end-systolic and end-diastolic diameters (LVESD, LVEDD), systolic and diastolic function. Timepoint: Echocardiographic measurements including LVESD, LVEDD at baseline. and at 6-month after the start of chemoterapy. Method of measurement: Echocardiography measurements by a specialist. Mashhad University of Medical Sciences Approved 2024-08-04 Ethics committee of Mashhad University of Medical Sciences Qureshi Building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)