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

Not Applicable

• Conditions: Breast Neoplasms
• Interventions: Drug: Mitoquinone; Other: Placebo

• Registration Number: NCT05146843
• Lead Sponsor: D'Or Institute for Research and Education

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-11-24
• Study First Posted: 2021-12-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-08
• Study Start: 2022-06-02
• Primary Completion: 2022-11-01
• Study Completion: 2023-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

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Exclusion Criteria

• Patients with metastasis, severe lymphedema, renal failure, acute myocardial infarction, heart failure, stroke and chronic liver disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitoquinone	Mitoquinone	MitoQ, 20 mg per day for three months
Placebo	Placebo	Placebo, 20 mg per day for three months

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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