Breast Neoplasms
Conditions
Keywords
Breast Cancer, Doxorrubicin, Mitoquinone, Cardiotoxicity, Peripheral vascular function
Brief summary
Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.
Detailed description
Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents: 1. increased mitochondrial oxidative stress; 2. the increase in cardiac markers (B-type natriuretic peptide and troponin I); 3. changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF; 4. endothelium-dependent dysfunction of peripheral vascular beds; 5. the increase in endothelial microvesicles; 6. the increase in material stiffness; 7. the elevation of central blood pressure.
Interventions
DRUGMitoquinone
Mitoquinone pill, 20 mg/day
OTHERPlacebo
Placebo pill, 20 mg/day
Sponsors
InCor Heart Institute
Instituto do Cancer do Estado de São Paulo
D'Or Institute for Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Clinical, randomized, double-blind, placebo-controlled trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old, diagnosed with breast cancer (ductal, lobular and mixed carcinoma), in stage 1-3, with indication for the adjuvant AC-T therapeutic scheme, doxorubicin (60 mg/m2) plus cyclophosphamide, will be considered eligible for the study (600 mg/m2) in the regimen of 1 cycle every 21 days, followed by weekly taxane for 12 cycles.
Exclusion criteria
* Patients with metastasis, severe lymphedema, renal failure, acute myocardial infarction, heart failure, stroke and chronic liver disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of the left ventricular deformity and reduction in left ventricular ejection fraction | 3 Months | Cardiac function changes (Strain and Simpson's monoplanar) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic markers of oxidative stress | 3 Months | Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I); |
| Endothelium-dependent dysfunction of peripheral vascular beds | 3 Months | changes in the endothelium-dependent function of peripheral vascular beds |
| Arterial stiffness | 3 Months | Increase in the arterial stiffness |
| Central blood pressure | 3 Months | Alterations on the central blood pressure |
| Physical capacity | 3 Months | Reduction in the peak oxygen uptake |
Contacts
Primary ContactAllan Kluser Sales, PhD
Outcome results
None listed