Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

Breast Cancer Clinical Trial

— Ceccy  

Official title:

Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity. A Randomized Double Blind Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01724450
• Other study ID #: Ceccy Trial
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2012
• Last updated: January 31, 2018
• Start date: April 2013
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ß-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptor blockers or ß-blockers.

Patients with HER 2 expression

Related Conditions & MeSH terms

• Breast Cancer
• Cardiotoxicity
• Heart Failure

Intervention

Drug:
• Carvedilol
50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
• Placebo
Placebo similar to the carvedilol up titration but wit no active drug.

Locations

Country	Name	City	State
Brazil	Heart Institute University of Sao Paulo	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Hospital A.C. Camargo, Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle.		96 weeks
Secondary	Prevention of myocardial injury measured by the levels of biomarkers (ultrasensitive troponin, BNP and miRNA-208) Effect of carvedilol in the prevention of diastolic dysfunction.		96 weeks