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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05146843
• Other study ID #: 48347821.8.0000.5249
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: December 2, 2023

Study information

• Verified date: March 2022
• Source: D'Or Institute for Research and Education
• Contact: Allan Kluser Sales, PhD
• Phone: 55+21996482036
• Email: allan.sales[@]idor.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Mitoquinone
Mitoquinone pill, 20 mg/day

Other:
• Placebo
Placebo pill, 20 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	InCor Heart Institute, Instituto do Cancer do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of the left ventricular deformity and reduction in left ventricular ejection fraction	Cardiac function changes (Strain and Simpson's monoplanar)	3 Months
Secondary	Systemic markers of oxidative stress	Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I);	3 Months
Secondary	Endothelium-dependent dysfunction of peripheral vascular beds	changes in the endothelium-dependent function of peripheral vascular beds	3 Months
Secondary	Arterial stiffness	Increase in the arterial stiffness	3 Months
Secondary	Central blood pressure	Alterations on the central blood pressure	3 Months
Secondary	Physical capacity	Reduction in the peak oxygen uptake	3 Months