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IRCT20190224042818N1 IRCT 2019-02-27 Mashhad University of Medical Sciences Investigation of the Effect of Curcumin in preventing complications of chemotherapy Investigation of the Effect of Curcumin on Preventing Anthracycline-Induced Cardiomyopathy in Patients with Breast Cancer - A Randomized Clinical Trial Study 2019-03-06 anticipated 40 Complete https://irct.ir/trial/37756 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using Random Allocation Software, random blocks with different volumes of 4 to 8 randomly spaced two color papers are concealed in envelopes and delivered to the secretary at Chemotherapy Dept. The secretary will draw the first upper color paper from the envelope for each patient. The medication or placebo, which will be blind for the secretary, is delivered to the patient according to the color of the paper. The patients initials along with the color of paper will be recorded in a list for further tracking, Blinding description: The patient, the secretary, the oncologist, and the echoman (cardiologist) will be blinded to the study. 3 Breast Cancer. Intervention 1: Intervention group: Nano-Comintern at a dose of 80 mg/day (Exir Nano Sina Co., Iran) is given orally form for 7 consecutive days before chemotherapy until 6 months later. Intervention 2: Control group: placebo is commenced 7 days before starting chemotherapy and will be continued for 6 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Hassan Mehrad-Majd
Ghaem Hospital, AhmadAbad Ave.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2694 mehradmajdh@mums.ac.ir Mashhad University of Medical Sciences scientific Hassan Mehrad-Majd
Ahmad-Abad Blvd
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2694 mehradmajdh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with breast cancer who planned for antracycline-based chemotherapy 18 years no limit Female presence of cardiomyopathy (dilated, restrictive or hypertro-phic) detected by baseline echocardiography Past medical history of coronary heart disease Moderate or severe aortic and/or mitral valve disease Prior chemotherapy or radiotherapy, Alcohol abuse Any contraindications to Curcumin 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: Nano-Comintern at a dose of 80 mg/day (Exir Nano Sina Co., Iran) is given orally form for 7 consecutive days before chemotherapy until 6 months later. Control group: placebo is commenced 7 days before starting chemotherapy and will be continued for 6 months 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 2018-07-18 Ethics committee of Mashhad University of Medical Sciences Faculty of Medicine, Azadi Square, Pardis campus Mashhad Razavi Khorasan Iran (Islamic Republic of)