The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients
Primary Purpose
Breast Neoplasms
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mitoquinone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast Cancer, Doxorrubicin, Mitoquinone, Cardiotoxicity, Peripheral vascular function
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mitoquinone
Placebo
Arm Description
MitoQ, 20 mg per day for three months
Placebo, 20 mg per day for three months
Outcomes
Primary Outcome Measures
Changes of the left ventricular deformity and reduction in left ventricular ejection fraction
Cardiac function changes (Strain and Simpson's monoplanar)
Secondary Outcome Measures
Systemic markers of oxidative stress
Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I);
Endothelium-dependent dysfunction of peripheral vascular beds
changes in the endothelium-dependent function of peripheral vascular beds
Arterial stiffness
Increase in the arterial stiffness
Central blood pressure
Alterations on the central blood pressure
Physical capacity
Reduction in the peak oxygen uptake
Full Information
NCT ID
NCT05146843
First Posted
November 24, 2021
Last Updated
March 31, 2022
Sponsor
D'Or Institute for Research and Education
Collaborators
InCor Heart Institute, Instituto do Cancer do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT05146843
Brief Title
The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2, 2022 (Anticipated)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
D'Or Institute for Research and Education
Collaborators
InCor Heart Institute, Instituto do Cancer do Estado de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast Cancer, Doxorrubicin, Mitoquinone, Cardiotoxicity, Peripheral vascular function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical, randomized, double-blind, placebo-controlled trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mitoquinone
Arm Type
Experimental
Arm Description
MitoQ, 20 mg per day for three months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 20 mg per day for three months
Intervention Type
Drug
Intervention Name(s)
Mitoquinone
Other Intervention Name(s)
MitoQ
Intervention Description
Mitoquinone pill, 20 mg/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo pill, 20 mg/day
Primary Outcome Measure Information:
Title
Changes of the left ventricular deformity and reduction in left ventricular ejection fraction
Description
Cardiac function changes (Strain and Simpson's monoplanar)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Systemic markers of oxidative stress
Description
Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I);
Time Frame
3 Months
Title
Endothelium-dependent dysfunction of peripheral vascular beds
Description
changes in the endothelium-dependent function of peripheral vascular beds
Time Frame
3 Months
Title
Arterial stiffness
Description
Increase in the arterial stiffness
Time Frame
3 Months
Title
Central blood pressure
Description
Alterations on the central blood pressure
Time Frame
3 Months
Title
Physical capacity
Description
Reduction in the peak oxygen uptake
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Kluser Sales, PhD
Phone
55+21996482036
Email
allan.sales@idor.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Kluser Sales, PhD
Organizational Affiliation
D'Or Institute of Research and Education
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients
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