Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy

Launched by HOSPITAL SIRIO-LIBANES · Jun 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called carvedilol on heart health in cancer patients who are receiving a type of chemotherapy known as anthracyclines. Anthracyclines are effective for treating certain cancers but can sometimes harm the heart, leading to serious complications. The researchers want to find out if carvedilol, which is known to help protect the heart, can prevent heart problems in these patients.

To participate in the trial, you need to be at least 18 years old and scheduled to receive anthracycline chemotherapy. You should not have any previous heart conditions or serious health issues that could affect your participation. If you join the study, you will receive either carvedilol or a placebo (a harmless pill with no active medication) for comparison, and you will be monitored closely for any changes in heart function. This trial aims to improve the safety of cancer treatments and enhance the quality of life for patients undergoing chemotherapy.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • ≥18 years of age at the time of screening
• • Cancer patients that will receive chemotherapy with anthracyclines.
• Exclusion Criteria:
• • Inability to adequate asses left ventricular function
• • Previous symptoms (dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, and pulmonary and systemic congestion) suggestive of or a previous diagnosis of heart failure.
• • Previous history of any cardiomyopathy (eg.: valve disease, Chagas' disease, infiltrative cardiomyopathy)
• • LVEF \< 50%
• • Previous history of myocardial revascularization
• • Permanent tachyarrhythmia (flutter, atrial fibrillation, atrial tachycardia)
• • Congenital heart disease with left ventricular function impared
• • Contra-indication to the use of beta-blockers.
• • Pregnant or Breast-feeding females or women of childbearing age who intend to became pregnant.
• • On kidney replacement therapy
• • ECOG \>= 4 or Karnofsky \<=30
• • Advanced hepatic failure (C score Child-Pugh and MELD \> 15);
• • Previous use of anthracycline
• • Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study
• • Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study