Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy (CardioTox)
Cancer
About this trial
This is an interventional prevention trial for Cancer focused on measuring Carvedilol, Anthracyclines, Cardiotoxicity, Chemotherapy
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 history 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)
- Contra-indication to the use of beta-blockers.
- Trastuzumab indication
- Pregnant or Breast-feeding females.
- 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
Sites / Locations
- Hospital Sirio LibanesRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intervention Group
Control Group
Patients allocated to the intervention group will receive carvedilol 6.25 mg twice daily, then increased to 12.5 mg twice daily, until maximum dose of 25 mg twice daily according to the patients' tolerance; The dosis increments will occur every 5 days. If after the increment the patient develops bradycardia or hypotension, the dose will be reduced to the maximum tolerated dose. Carvedilol will ideally be maintained for up to 30 days after the end of chemotherapy.
Patients allocated to this group will receive placebo in a presumably staggered and progressive manner similar to the group intervention. The placebo will ideally be maintained for up to 30 days after the end of chemotherapy.