The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients
Study Details
Study Description
Brief Summary
Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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N/A |
Detailed Description
Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents:
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increased mitochondrial oxidative stress;
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the increase in cardiac markers (B-type natriuretic peptide and troponin I);
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changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF;
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endothelium-dependent dysfunction of peripheral vascular beds;
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the increase in endothelial microvesicles;
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the increase in material stiffness;
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the elevation of central blood pressure.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Mitoquinone MitoQ, 20 mg per day for three months |
Drug: Mitoquinone
Mitoquinone pill, 20 mg/day
Other Names:
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Placebo Comparator: Placebo Placebo, 20 mg per day for three months |
Other: Placebo
Placebo pill, 20 mg/day
|
Outcome Measures
Primary Outcome Measures
- Changes of the left ventricular deformity and reduction in left ventricular ejection fraction [3 Months]
Cardiac function changes (Strain and Simpson's monoplanar)
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- D'Or Institute for Research and Education
- InCor Heart Institute
- Instituto do Cancer do Estado de São Paulo
Investigators
- Principal Investigator: Allan Kluser Sales, PhD, D'Or Institute of Research and Education
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 48347821.8.0000.5249