Carvedilol's effects on heart damage in cancer patients receiving chemotherapy

A Prospective Multi-Center Randomized Study to Evaluate the Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy

This study is testing if the heart medication carvedilol can help protect cancer patients from heart damage while they receive chemotherapy.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 1018 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital Sirio-Libanes (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (São Paulo, Sao Paulo)
• Trial ID: NCT04939883 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of carvedilol, a beta-blocker, on reducing cardiotoxicity in cancer patients undergoing anthracycline chemotherapy. The study aims to determine whether carvedilol can protect the heart from damage caused by these chemotherapy agents, which are known to increase the risk of heart failure. Participants will be randomly assigned to receive either carvedilol or a placebo, and their heart function will be monitored throughout the treatment. The trial focuses on adult cancer patients who are about to start anthracycline therapy.

Who should consider this trial

Good fit: Ideal candidates for this study are adult cancer patients aged 18 and older who are scheduled to receive anthracycline chemotherapy.

Not a fit: Patients with pre-existing heart conditions or those who cannot tolerate beta-blockers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the heart health and overall quality of life for cancer patients undergoing chemotherapy.

How similar studies have performed: Other studies have shown promising results in using beta-blockers to mitigate cardiotoxicity in cancer patients, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* ≥18 years of age at the time of screening
* Cancer patients that will receive chemotherapy with anthracyclines.

Exclusion Criteria:

* Inability to adequate asses left ventricular function
* Previous symptoms (dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, and pulmonary and systemic congestion) suggestive of or a previous diagnosis of heart failure.
* Previous history of any cardiomyopathy (eg.: valve disease, Chagas' disease, infiltrative cardiomyopathy)
* LVEF \< 50%
* Previous history of myocardial revascularization
* Permanent tachyarrhythmia (flutter, atrial fibrillation, atrial tachycardia)
* Congenital heart disease with left ventricular function impared
* Contra-indication to the use of beta-blockers.
* Pregnant or Breast-feeding females or women of childbearing age who intend to became pregnant.
* On kidney replacement therapy
* ECOG \>= 4 or Karnofsky \<=30
* Advanced hepatic failure (C score Child-Pugh and MELD \> 15);
* Previous use of anthracycline
* Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study
* Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Where this trial is running

São Paulo, Sao Paulo

• Hospital Sirio Libanes — São Paulo, Sao Paulo, Brazil (RECRUITING)

Study contacts

• Principal investigator: Renato H D. lopes, MD, PhD — Hospital Sírio-Libanês
• Study coordinator: Ana Cecilia A Silva, MD, PhD

Conditions: Cancer, Carvedilol, Anthracyclines, Cardiotoxicity, Chemotherapy