Doxorubicin-induced cardiotoxicity Cancer
Conditions
Interventions
The participants (female patients with breast cancer) are randomised into one of two groups:
1. The study group will be exposed for a short period to a high dose of DHA (1500 mg/day a
Sponsors
Scientific and Technological Development Fund (FONDECYT; Fondo de Desarrollo Científico y Tecnológico) (Chile)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Females aged between 18 and 75 years old 2. Breast Cancer Diagnosis 3. Entering first cycle of chemotherapy 4. Performance status of 0-2 in the Eastern Cooperative Oncology Group (ECOG) score. 5. Subject must be able and willing to sign an informed consent
Exclusion criteria
Exclusion criteria: 1. History of renal (serum creatinine greater than 2 mg / ml) or hepatic insufficiency (bilirubin> 3.0 mg / dl or serum albumin <3.5 g / dl or prothrombin time <60% in the absence of oral anticoagulant therapy or ultrasound signs of chronic liver damage) 2. History of heart failure 3. History of cardiac valvulopathy 4. Baseline LVEF <50% determined by transthoracic echocardiogram 5. Cardiogenic shock 6. Any serious medical co-morbidity that determine life expectancy < 6 months 7. Current participation in any other clinical investigation 8. Any condition that contraindicates chemotherapy (i.e. Pregnancy, Lactation) 9. History of severe adverse reaction to carvedilol 10. History of severe adverse reaction to DHA 11. Previous treatment with beta-blockers within the last 3 months 12. Use of Vitamin E, Vitamin C or probucol, during the last three months 13. Use of oral anticoagulants 14. History of coagulation disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Affected tissue and cardiac remodeling at six months, measured using cardiac magnetic resonance at baseline and 3 months after the end of chemotherapy 2. Change from baseline in global LVEF, measured using echocardiogram and cardiac magnetic resonance. Ecocardiogram is taken measure at baseline, 3 and 6 months after the end of chemotherapy, MRI at baseline and 3 months after the end of chemotherapy 3. Change from baseline in corrected QT Interval via electrocardiogram, at baseline, day 2, 4 and 3 months after the end of chemotherapy Previous: 4. Change from baseline in NT-ProBNP, via plasmatic levels, measured at baseline, day 2, 4 and 3 months after the end of chemotherapy Current as of 25/02/2019: 4. Change from baseline in NT-ProBNP and hs-cTnT, via plasmatic levels, measured at baseline, day 2, 4 and 3 months after the end of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lipid peroxidation (Malondialdehyde levels) at baseline, day 2, day 4 and 3 months after chemotherapy 2. Erythrocyte antioxidant enzymes activity (SOD, CAT, GSH-Px) at baseline, day 2, day 4 and 3 months after chemotherapy 3. Erythrocyte Tiol Index (GSH/GSSG), at baseline, day 2, day 4 and 3 months after chemotherapy 4. Ferric reducing ability of plasma (FRAP) at baseline, day 2, day 4 and 3 months after chemotherapy | — |
Countries
Chile
Outcome results
None listed