Your session is about to expire
← Back to Search
Beta Blocker
Carvedilol for Preventing Heart Failure in Childhood Cancer Survivors
Phase 2
Waitlist Available
Led By Saro H Armenian
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have had a cancer diagnosis < 22 years of age, irrespective of current age
Patient must have a lifetime cumulative anthracycline dose of >= 250 mg/m^2 DOXOrubicin equivalent without the protection of dexrazoxane (Zinecard) therapy; the anthracycline dose threshold must be met as part of the treatment of a cancer that was diagnosed at < 22 years of age
Must not have
Endocrine disorders (such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism) not controlled with medication
Uncontrolled diabetes (controlled diabetes per the American Diabetes Association and International Diabetes Center's Glycemic Target Goals is hemoglobin A1C < 7%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up responses at days 14 to 730 were combined
Summary
This trial tests how well low-dose carvedilol prevents heart failure in cancer survivors who were exposed to high-dose anthracyclines. Carvedilol may help lower the risk of cardiovascular complications.
Who is the study for?
This trial is for childhood cancer survivors who are now at risk of heart failure due to high-dose anthracycline chemotherapy. Participants must weigh at least 40 Kg, have been diagnosed with cancer before age 22, finished treatment at least 2 years ago, and received a certain amount of anthracycline without dexrazoxane protection.
What is being tested?
The study tests if low-dose Carvedilol can prevent heart failure in those exposed to high doses of anthracyclines during childhood cancer treatment. It includes lab biomarker analysis, pharmacogenomic and pharmacological studies, placebo comparison, quality-of-life assessment, and questionnaires.
What are the potential side effects?
Carvedilol may cause side effects such as dizziness or lightheadedness (due to lowered blood pressure), fatigue, digestive issues like nausea or diarrhea, changes in weight or cholesterol levels. Some people might also experience slower heart rates.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with cancer before turning 22.
Select...
I received a high dose of a specific chemotherapy drug for cancer treated before I was 22.
Select...
I weigh at least 40 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My hormone-related condition is not controlled by medication.
Select...
My diabetes is under control with an A1C level below 7%.
Select...
I am currently taking specific medications that affect drug metabolism.
Select...
I am not pregnant and have a negative pregnancy test.
Select...
I have a serious heart rhythm problem.
Select...
I have moderate-to-severe lung problems like asthma that need treatment.
Select...
I do not have severe heart valve problems or thickened heart muscles causing obstruction.
Select...
I am currently being treated for heart issues.
Select...
I have heart rhythm problems not controlled by medication or devices.
Select...
I cannot swallow pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ responses at days 14 to 730 were combined
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~responses at days 14 to 730 were combined
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Average Left-Ventricular Wall Thickness-Dimension Ratio Z-score (LVWT/Dz)
Secondary study objectives
Average Alanine Aminotransferase
Average Aspartate Aminotransferase
Average Bilirubin
+16 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (carvedilol)Experimental Treatment6 Interventions
Patients receive low-dose carvedilol PO QD or BID for 24 months.
Group II: Arm II (placebo)Placebo Group6 Interventions
Patients receive placebo PO QD or BID for 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carvedilol
2011
Completed Phase 4
~1410
Find a Location
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,802 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,891 Total Patients Enrolled
2 Trials studying Blood Cancers
112 Patients Enrolled for Blood Cancers
Saro H ArmenianPrincipal InvestigatorChildren's Oncology Group
3 Previous Clinical Trials
1,390 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood doesn't have enough red cells.I don't have stomach or liver problems affecting medication absorption.My hormone-related condition is not controlled by medication.My diabetes is under control with an A1C level below 7%.I am currently taking specific medications that affect drug metabolism.I am not pregnant and have a negative pregnancy test.I have a serious heart rhythm problem.Your heart's ability to pump blood is too low, as measured by specific tests.I received a high dose of a specific chemotherapy drug for cancer treated before I was 22.I was diagnosed with cancer before turning 22.Your resting systolic blood pressure is less than 90 mmHg.I have moderate-to-severe lung problems like asthma that need treatment.I haven't taken any blood pressure medication except for calcium channel blockers or diuretics in the last 30 days.I do not have severe heart valve problems or thickened heart muscles causing obstruction.Your liver enzymes (AST and ALT) are more than three times the normal limit.You have had a bad reaction to alpha or beta-blocker medications in the past.I am using effective birth control or practicing abstinence while on the study drug and for 2 months after.I am currently being treated for heart issues.I have heart rhythm problems not controlled by medication or devices.Your heart beats too slowly, less than 50 beats per minute.I haven't taken any experimental drugs or beta blockers like metoprolol in the last 30 days.I cannot swallow pills.I weigh at least 40 kg.I finished my cancer treatment more than 2 years ago.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (carvedilol)
- Group 2: Arm II (placebo)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.