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

Sponsor
D'Or Institute for Research and Education (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05146843
Collaborator
InCor Heart Institute (Other), Instituto do Cancer do Estado de São Paulo (Other)
44
2
18

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Clinical, randomized, double-blind, placebo-controlled trial.Clinical, randomized, double-blind, placebo-controlled trial.
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 2, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 2, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mitoquinone

MitoQ, 20 mg per day for three months

Drug: Mitoquinone
Mitoquinone pill, 20 mg/day
Other Names:
  • MitoQ
  • Placebo Comparator: Placebo

    Placebo, 20 mg per day for three months

    Other: Placebo
    Placebo pill, 20 mg/day

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Systemic markers of oxidative stress [3 Months]

      Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I);

    2. Endothelium-dependent dysfunction of peripheral vascular beds [3 Months]

      changes in the endothelium-dependent function of peripheral vascular beds

    3. Arterial stiffness [3 Months]

      Increase in the arterial stiffness

    4. Central blood pressure [3 Months]

      Alterations on the central blood pressure

    5. Physical capacity [3 Months]

      Reduction in the peak oxygen uptake

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • D'Or Institute for Research and Education
    • InCor Heart Institute
    • Instituto do Cancer do Estado de São Paulo

    Investigators

    • Principal Investigator: Allan Kluser Sales, PhD, D'Or Institute of Research and Education

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allan Robson Kluser Sales, PhD, D'Or Institute for Research and Education
    ClinicalTrials.gov Identifier:
    NCT05146843
    Other Study ID Numbers:
    • 48347821.8.0000.5249
    First Posted:
    Dec 7, 2021
    Last Update Posted:
    Apr 8, 2022
    Last Verified:
    Mar 1, 2022
    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
    Keywords provided by Allan Robson Kluser Sales, PhD, D'Or Institute for Research and Education
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2022