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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up responses at days 14 to 730 were combined
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I was diagnosed with cancer before turning 22.
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I received a high dose of a specific chemotherapy drug for cancer treated before I was 22.
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I weigh at least 40 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~responses at days 14 to 730 were combined
This trial's timeline: 3 weeks for screening, Varies for treatment, and responses at days 14 to 730 were combined for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average Left-Ventricular Wall Thickness-Dimension Ratio Z-score (LVWT/Dz)
Secondary outcome measures
Average Alanine Aminotransferase
Average Aspartate Aminotransferase
Average Bilirubin
+16 more

Trial 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
453 Previous Clinical Trials
237,504 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,957 Total Patients Enrolled
1 Trials studying Blood Cancers
70 Patients Enrolled for Blood Cancers
Saro H ArmenianPrincipal InvestigatorChildren's Oncology Group
3 Previous Clinical Trials
1,270 Total Patients Enrolled

Media Library

Carvedilol (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT02717507 — Phase 2
Blood Cancers Research Study Groups: Arm I (carvedilol), Arm II (placebo)
Blood Cancers Clinical Trial 2023: Carvedilol Highlights & Side Effects. Trial Name: NCT02717507 — Phase 2
Carvedilol (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02717507 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many hospitals is this trial being conducted?

"87 clinical trial sites are currently participating in this study, with locations spanning from Baltimore to Hackensack. If you're interested in enrolling, we recommend finding the location nearest to you in order to cut down on travel costs and time commitment."

Answered by AI

Is there a risk to patients when they answer questions for a study?

"While there is some evidence that this questionnaire administration is safe, it only received a 2 because there is no data supporting efficacy."

Answered by AI

What are some other examples of research that has used questionnaire administration?

"The first clinical trial studying Questionnaire Administration occurred in 2012 at the University of Calgary. Out of the 837 completed trials, 29 are still ongoing with several taking place in Baltimore, Maryland."

Answered by AI

What disorders does Questionnaire Administration help to alleviate symptoms for?

"While hypertensive disease is most frequently treated with Questionnaire Administration, this method can also be used to mitigate the effects of heart failure, hypesthesia, and left ventricular dysfunction."

Answered by AI

How many people are included in this research project?

"Unfortunately, this particular trial has wrapped up recruitment. Though, it is worth noting that there are plenty of other studies currently underway that may be of interest. For example, there are 3240 trials actively recruiting cancer patients and 29 for Questionnaire Administration."

Answered by AI

Are there any more places open for people who want to participate in this experiment?

"This clinical trial is not presently seeking participants anymore. The clinical trial was originally posted on 4/4/2016 and was most recently edited on 9/30/2022. If you are seeking for other studies, there are presently 3240 clinical trials actively recruiting participants with cancer and 29 trials for Questionnaire Administration actively looking for patients."

Answered by AI
~22 spots leftby Apr 2025