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

NCT05146843 | Unknown

• 1 other identifier: 48347821.8.0000.5249
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Doxorrubicin; Mitoquinone; Cardiotoxicity; Peripheral vascular function

Outcome Measures

Primary Outcomes (1)

• Changes of the left ventricular deformity and reduction in left ventricular ejection fraction

  Cardiac function changes (Strain and Simpson's monoplanar)

  3 Months

Secondary Outcomes (5)

• Systemic markers of oxidative stress

  3 Months

• Endothelium-dependent dysfunction of peripheral vascular beds

  3 Months

• Arterial stiffness

  3 Months

• Central blood pressure

  3 Months

• Physical capacity

  3 Months

Study Arms (2)

Mitoquinone

EXPERIMENTAL

MitoQ, 20 mg per day for three months

Drug: Mitoquinone

Placebo

PLACEBO COMPARATOR

Placebo, 20 mg per day for three months

Other: Placebo

Interventions

Mitoquinone DRUG

Mitoquinone pill, 20 mg/day

Also known as: MitoQ

Mitoquinone

Placebo OTHER

Placebo pill, 20 mg/day

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Allan Kluser Sales, PhD

  D'Or Institute of Research and Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Kluser Sales, PhD

CONTACT

55+21996482036; allan.sales@idor.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Clinical, randomized, double-blind, placebo-controlled trial.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: June 2, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 2, 2023
• Last Updated: April 8, 2022

Record last verified: 2022-03