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Randomized Double Blind Study on the Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity.


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Heart Failure, Cardiotoxicity

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Trial Information

Randomized Double Blind Study on the Effect of Beta-Blockers in Preventing Chemotherapy - Induced Cardiotoxicity.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle.

Outcome Time Frame:

96 weeks

Safety Issue:

Yes

Principal Investigator

Edimar Alcides Bocchi, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Heart Institute of University of Sao Paulo

Authority:

Brazil: Ethics Committee

Study ID:

Cardiotox Incor

NCT ID:

NCT01724450

Start Date:

June 2012

Completion Date:

June 2016

Related Keywords:

  • Breast Cancer
  • Heart Failure
  • Cardiotoxicity
  • Breast Cancer
  • Heart Failure
  • Cardiotoxicity
  • Biomarkers
  • Breast Neoplasms
  • Heart Failure

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