The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients

Study Overview
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Brief Summary
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Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.

Detailed Description
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Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents: increased mitochondrial oxidative stress; the increase in cardiac markers (B-type natriuretic peptide and troponin I); changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF; endothelium-dependent dysfunction of peripheral vascular beds; the increase in endothelial microvesicles; the increase in material stiffness; the elevation of central blood pressure.

Official Title
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The Impact of Chronic Mitochondrial Antioxidant (MitoQ) Supplementation on Cardiovascular Toxicity Induced by Doxorubicin-Based Adjuvant Chemotherapy in Breast Cancer Patients: Randomized Clinical Trial

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Mitoquinone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical, randomized, double-blind, placebo-controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitoquinone<br>MitoQ, 20 mg per day for three months | Drug: Mitoquinone<br>* Mitoquinone pill, 20 mg/day<br>* Other names: MitoQ;|
| Placebo Comparator: Placebo<br>Placebo, 20 mg per day for three months | Other: Placebo<br>* Placebo pill, 20 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the left ventricular deformity and reduction in left ventricular ejection fraction | Cardiac function changes (Strain and Simpson's monoplanar) | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic markers of oxidative stress | Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I); | 3 Months | 
| Endothelium-dependent dysfunction of peripheral vascular beds | changes in the endothelium-dependent function of peripheral vascular beds | 3 Months | 
| Arterial stiffness | Increase in the arterial stiffness | 3 Months | 
| Central blood pressure | Alterations on the central blood pressure | 3 Months | 
| Physical capacity | Reduction in the peak oxygen uptake | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Doxorrubicin, Mitoquinone, Cardiotoxicity, Peripheral vascular function