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Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy

Study acronym: CardioTox
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary and study completion dates: Dec 30, 2025 to May 31, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  2. Minor Eligibility criteria expanded, about 34 words
    • Secondary endpoints revised (6)
    v6
  3. Notable Primary completion date: Dec 30, 2023 to Dec 30, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    • Site contact updated
    v5
  4. Notable Primary completion date: Jun 30, 2023 to Dec 30, 2023v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 1, 2021 to Aug 1, 2021
    • Site details revised
    v3
  6. Minor Secondary endpoints revised (6)v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Neoplasia is the main cause of general death in the Brazilian population. In 2016, they were responsible for approximately 211,343 (16%) deaths, followed by cardiovascular diseases (12.6%). Despite the high mortality rate of neoplasia, oncological treatment have advanced substantially in recent decades improving the prognosis of patients. However, growing evidence suggest that some oncological agents may induce significant toxicity that may play a major role in the quality of life, morbidity and mortality. The cardiovascular system is often negatively affected with cancer therapy, predisposing several patients to stop appropriate treatments or to have cardiovascular events related to the cardiotoxicity. The most typical manifestation of cardiotoxicity and related consequences (heart failure) are related to the use of anthracyclines. Anthracyclines are part of the chemotherapy regimen for solid tumors and hematological neoplasms in children and adults, and are associated with an increase in life expectancy. Carvedilol is an α and β-blocker that also has antioxidant properties. Preliminary studies have shown that carvedilol and its metabolites prevent lipid peroxidation, inhibit the formation and inactivate free radicals, in addition to preventing the depletion of endogenous antioxidants, such as vitamin E. These effects would potentially prevent anthracycline injury but definitive evidence is still needed. This is a multi-center, double-blind, randomized, placebo-controlled study that aims to establish the efficacy of carvedilol for the primary prevention of left ventricular systolic dysfunction in cancer patients obtained with anthracycline chemotherapy, in different schedules and doses.
Trial Details
NCT Number NCT04939883
Lead Sponsor Hospital Sirio-Libanes
Collaborators: Ministry of Health, Brazil
Conditions
(from sponsor)
Cancer
Related terms Cardiotoxicity, Neoplasms
Enrollment 1,018 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov