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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
D'Or Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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