Carvedilol Effect in Preventing Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-06-30

Brief Summary

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The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after chemotherapy in breast cancer.

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Detailed Description

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Dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all dilated cardiomyopathies.

Initial studies showed beneficial effect of the use of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. This study has the objective to evaluate the effectiveness of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. Will be selected 200 patients referred for chemotherapy that includes anthracyclines for breast cancer.These patients will be randomized to carvedilol or placebo and will have periodic assessment of cardiac function with echocardiography and biomarkers until complete chemotherapy and 24 months later.

Conditions

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Breast Cancer Heart Failure Cardiotoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Carvedilol

Group Type ACTIVE_COMPARATOR

Carvedilol

Intervention Type DRUG

50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo similar to the carvedilol up titration but wit no active drug.

Interventions

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Carvedilol

50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day

Intervention Type DRUG

Placebo

Placebo similar to the carvedilol up titration but wit no active drug.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients diagnosed with breast cancer, with an indication of chemotherapy that includes anthracycline.

Exclusion Criteria

Failure analysis of ventricular function; History of chemotherapy or radiotherapy; Previous symptoms of heart failure; Presence of cardiomyopathy; Presence of Coronary Artery Disease; Aortic valve disease or moderate to severe mitral regurgitation; Contraindication to the use of β-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptor blockers or β-blockers.

Patients with HER 2 expression

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No