Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy

Launched by ARAB CONTRACTORS MEDICAL CENTRE · Mar 8, 2024

Keywords

ClinConnect Summary

The BASiC-CIC Trial is a research study designed to see if colchicine, a medication that is usually used for gout, can help prevent heart problems caused by certain chemotherapy drugs. The trial will compare colchicine to a combination of other heart-protecting medications, like beta-blockers and ACE inhibitors, to determine if they can reduce the risk of heart issues and improve overall health for patients undergoing chemotherapy. This study is important because some chemotherapy treatments can lead to heart damage, which can be serious.

To participate in this trial, you must be a cancer patient who is about to start a specific type of chemotherapy and have a healthy heart function (with a heart pumping capacity of at least 50%). You will need to be able to give your consent for the study and meet certain health criteria. However, if you have severe heart disease, are critically ill, or have certain other health conditions like advanced kidney disease or are pregnant, you may not be eligible. If you join the trial, you will receive either the colchicine, the combination of heart medications, or a placebo (a non-active treatment) without knowing which one you're getting. This way, researchers can accurately see which treatment works best.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to provide written informed consent prior to performing study procedures.
• • A cancer patient who is a candidate for a guideline-directed, anthracycline-based chemotherapy with or without the anti-HER2 trastuzumab.
• • Baseline LVEF ≥ 50% without evident structural heart disease by pre-treatment echocardiographic examination.
• Exclusion Criteria:
• • Critically ill Cancer patients who are admitted to ICU.
• • Ischemic cardiomyopathy with LVEF ≤ 50%.
• • Dilated cardiomyopathy with LVEF ≤ 50%.
• • Advanced valvular heart disease (severe valvular affection in the form of stenosis or regurgitation).
• • Systolic BP \< 90 mmHg or diastolic BP \< 60 mmHg.
• • Liver cell failure.
• • End-stage chronic kidney disease on regular dialysis.
• • Pregnancy.
• • Lactation.
• • Chronic muscle diseases such as dermatomyositis, polymyositis, or muscular dystrophy.
• • Acute trauma or burns within 2 weeks.
• • History of allergy to the implemented drugs.