]>
IRCT20211109053025N1 IRCT 2022-01-07 Tehran University of Medical Sciences Evaluation of Melatonin efficacy in prophylaxis of Doxorubicin induced cardiotoxicity in patients with breast cancer and receiving the Doxorubicin-Cyclophosphamide regimen Evaluation of Melatonin efficacy in prophylaxis of Doxorubicin induced cardiotoxicity in patients with breast cancer and receiving the Doxorubicin-Cyclophosphamide regimen : Double-blind randomized clinical trial 2021-11-22 anticipated 56 Complete https://irct.ir/trial/59971 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly assigned to the study using block randomization in two groups receiving placebo chemotherapy regimen or melatonin chemotherapy regimen group. For this purpose, the patient and the researcher (student) and the doctors will be blind and the randomization operation will be performed by the executor of the project based on double or quadruple random tables and on each box, a number will be registered, the contents of which will be unknown, and in this way it will be given to the researcher and then the patient, Blinding description: Participants in the study, the physician who introduced them to the research team, the cardiologist who is responsible for measuring echocardiographic parameters in patients in both groups, and the laboratory staff who are responsible for measuring cardiac biomarkers in patients, the student who, as a researcher, makes the arrangements are blinded in this study. Using block randomization method which is done by the executor of the project and using two or four tables, each box containing the medicine or placebo is randomly assigned a number and that number is given to the researcher and the patient. 3 Condition 1: Breast cancer. Condition 2: drug-induced cardiomyopathy. Intervention 1: Intervention group: A group in which patients receive melatonin drug produced by Jalinous at a dose of 10 mg once in the evening along with chemotherapy. The patient will receive this drug from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen. Intervention 2: Control group: A group in which patients receive Placebo produced by Jalinous once in the evening along with chemotherapy. The patient will receive placebo from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen. No - There is not a plan to make this available Justification or reason for not sharing IPD is it is not necessary
public Seyed Mohamad Mousavinia
Cancer Institute, Imam Khomeini Hospital, Dr. Gharib St. , End of Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1599957113 +98 21 6658 1692 sm_mousavinia@razi.tums.ac.ir Tehran University of Medical Sciences scientific Seyed Mohamad Mousavinia
Cancer Institute, Imam Khomeini Hospital, Dr. Gharib St. , End of Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1599957113 +98 21 6658 1692 sm_mousavinia@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) People who have recently been definitively diagnosed with breast cancer and are candidates for a chemotherapy regimen containing doxorubicin Having the consent to participate in the study Age over 18 years Ability to consume orally Normal liver function (serum bilirubin less than 1.5 mg / dl) No CKD or SrCreatinine> 2 mg / dL or eGFR <30 mL / min / m2 18 years no limit Both Patients with a history of breast cancer or a history of chemotherapy drugs that cause cardiotoxicity Patients who are unable to receive doxorubicin for any reason Patient with LVEF <50% before starting treatment Use of ACE inhibitors, ARBs, beta-blockers or in the treatment of heart failure Having coronary or valvular heart disease, cardiomyopathy, hypertension or AF History of receiving chest radiotherapy Patients with neurological injuries such as Parkinson's, stroke, seizures, etc. Those who are taking an antioxidant drug such as vitamin E, NAC, etc. Participate in other clinical studies simultaneously Known sensitivity to any of the consumables in the study C50 142.7 Malignant neoplasm of breast cardiomyopathy due to drug and external agent Prevention Placebo Intervention group: A group in which patients receive melatonin drug produced by Jalinous at a dose of 10 mg once in the evening along with chemotherapy. The patient will receive this drug from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen. Control group: A group in which patients receive Placebo produced by Jalinous once in the evening along with chemotherapy. The patient will receive placebo from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen. LVEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction. Timepoint: Once at the beginning and once a week after the last chemotherapy session. Method of measurement: Using echocardiography performed by a cardiologist. GLS (Global longitudinal strain): A sensitive criterion used by echocardiography to measure myocardial deformity and left ventricular contractile strength and can aid in the early diagnosis of cardiotoxicity. A decrease of more than 15% compared to the beginning or an absolute value of -19% after the start of anthracyclines is associated with a significant increase in the risk of future LVEF reduction. Timepoint: At the beginning and one week after the last chemotherapy session. Method of measurement: Echocardiography by a cardiologist. Troponin I: One of the three types of troponin present in the body that is more specific to the myocardium of the heart and as a marker of the heart, can help diagnose myocardial damage. This enzyme increases within a few hours after heart damage and can last for a long time. Remain in my head for 10-14 days. Timepoint: Once at the beginning and twice at one week after the second and last session of chemotherapy. Method of measurement: Blood sampling and blood level measurement by laboratory. CK-MB: Creatine kinase and its MB isoenzyme are among the serological tests used to diagnose heart damage. This biomarker rises within the first 4 to 6 hours after heart injury and returns to baseline after 36 to 48 hours. Timepoint: Once at the beginning and twice at one week after the second and last session of chemotherapy. Method of measurement: Blood sampling and blood level measurement by laboratory. PSQI Score: The Pittsburgh Sleep Quality Index Questionnaire examines people's attitudes about sleep quality over the past four weeks. It has 7 components and each component gets a score from zero to three. The overall score is from zero to 21 and is obtained from the sum of the scores of the components. An overall score of 5 or higher indicates poor sleep quality. Timepoint: At the beginning, a month later and at the end of chemotherapy. Method of measurement: Using the PSQI questionnaire. ISI (Insomnia severity index) score: The index indicates the severity of insomnia, which includes 5 questions with intensity and scores from zero to 4. In the end, based on the overall score, which is from zero to 28, the severity of insomnia is determined. Timepoint: At the beginning, a month later and at the end of chemotherapy. Method of measurement: ISI questionnaire. HADS (Hospital Anxiety and Depression Scale) Score: A clinical scale for anxiety and depression that includes 14 questions. The score of the individual questions is the index of anxiety and the couple questions are the index of depression. The total score varies from zero to 21 and based on that, the person is defined as normal or abnormal. Timepoint: At the beginning, a month later and at the end of chemotherapy. Method of measurement: HADS questionnaire. EORTC score QLQ-c30: is a quality of life questionnaire in cancer patients that has been done in Persian for reliability and validity. Each question receives a score from 1 to 4 and is finally determined based on the total score of quality of life . Timepoint: First, one month later and end of the study. Method of measurement: Score from the questionnaire. Tehran University of Medical Sciences Approved 2021-12-25 The Institute of Pharmaceutical Sciences (TIPS) of the Tehran University of Medical Sciences Poursina Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences (TIPS), PO Box. 14176-13151, Iran Tehran Tehran Iran (Islamic Republic of)