Condition 1: Breast cancer. Condition 2: drug-induced cardiomyopathy. Malignant neoplasm of breast cardiomyopathy due to drug and external agent
Conditions
Interventions
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
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 indica | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Mohamad Mousavinia
Tehran University of Medical Sciences
Outcome results
None listed