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Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity (Ceccy)

Primary Purpose

Breast Cancer, Heart Failure, Cardiotoxicity

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Carvedilol
Placebo
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Heart Failure, Cardiotoxicity, Biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Institute University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Carvedilol

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 11, 2012
Last Updated
January 31, 2018
Sponsor
University of Sao Paulo
Collaborators
Hospital A.C. Camargo, Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01724450
Brief Title
Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity
Acronym
Ceccy
Official Title
Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity. A Randomized Double Blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Hospital A.C. Camargo, Instituto do Cancer do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Heart Failure, Cardiotoxicity
Keywords
Breast Cancer, Heart Failure, Cardiotoxicity, Biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Description
50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo similar to the carvedilol up titration but wit no active drug.
Primary Outcome Measure Information:
Title
Prevention of systolic dysfunction in patients undergoing chemotherapy with anthracycline. Systolic dysfunction is characterized by a 10% drop in ejection fraction of left ventricle.
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
96 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edimar Alcides Bocchi, PHD
Organizational Affiliation
Heart Institute of University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
35087624
Citation
Wanderley MRB Jr, Avila MS, Fernandes-Silva MM, Cruz FDD, Brandao SMG, Rigaud VOC, Hajjar LA, Filho RK, Cunha-Neto E, Bocchi EA, Ayub-Ferreira SM. Plasma biomarkers reflecting high oxidative stress in the prediction of myocardial injury due to anthracycline chemotherapy and the effect of carvedilol: insights from the CECCY Trial. Oncotarget. 2022 Jan 25;13:214-223. doi: 10.18632/oncotarget.28182. eCollection 2022.
Results Reference
derived
PubMed Identifier
29540327
Citation
Avila MS, Ayub-Ferreira SM, de Barros Wanderley MR Jr, das Dores Cruz F, Goncalves Brandao SM, Rigaud VOC, Higuchi-Dos-Santos MH, Hajjar LA, Kalil Filho R, Hoff PM, Sahade M, Ferrari MSM, de Paula Costa RL, Mano MS, Bittencourt Viana Cruz CB, Abduch MC, Lofrano Alves MS, Guimaraes GV, Issa VS, Bittencourt MS, Bocchi EA. Carvedilol for Prevention of Chemotherapy-Related Cardiotoxicity: The CECCY Trial. J Am Coll Cardiol. 2018 May 22;71(20):2281-2290. doi: 10.1016/j.jacc.2018.02.049. Epub 2018 Mar 11.
Results Reference
derived

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Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

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