Completed

Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity: A Pediatric Oncology Group Cancer Control Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

enalapril maleate

+ quality-of-life assessment

+ enalapril maleate

DrugProcedure
Who is being recruted

Cardiovascular Diseases+6

+ Heart Diseases

+ Pathologic Processes

Over 8 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 3
Interventional
Study Start: September 2000
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: August 5, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2000

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine whether enalapril treatment results in a reduction in body surface area-adjusted left ventricular mass in anthracycline-treated survivors of childhood cancer. II. Determine whether improvement in ventricular function achieved by enalapril is sustained and alters the course of late cardiotoxicity. III. Determine the impact of enalapril therapy on quality of life. OUTLINE: This is a double blind, placebo controlled, randomized study. Patients are stratified based on the cumulative anthracycline dose, age at cancer diagnosis, and the duration of time since cessation of anthracycline therapy. Patients are administered enalapril or placebo by mouth bid. Patients undergo a series of cardiac tests after administration of drug. Follow-up occurs at 2, 6, and 12 months and every year thereafter. PROJECTED ACCRUAL: 75 patients in each treatment arm will be accrued.

NCT00003070
Principal SponsorChildren's Oncology Group
Last updated: August 5, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

13 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 8 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesPathologic ProcessesRadiation InjuriesPathological Conditions, Signs and SymptomsWounds and InjuriesChemically-Induced DisordersDrug-Related Side Effects and Adverse ReactionsCardiotoxicity

Criteria

DISEASE CHARACTERISTICS: Histologically diagnosed childhood malignancy that had prior anthracycline therapy Echocardiographic evidence of reduced fractional shortening, reduced contractility, or increased afterload, or any combination At least 6 months oncologic disease free PATIENT CHARACTERISTICS: Age: At least 8 at study entry and less than 22 at diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No history of renal disease No known renal artery stenosis Cardiovascular: No congenital cardiovascular malformations No active congestive heart failure not attributable to sepsis or renal failure No medication for heart condition No history of symptomatic arrhythmia antedating anthracycline therapy No constrictive pericarditis No uncontrolled hypertension Pulmonary: No primary valvular or outflow tract obstruction Other: Not pregnant or lactating Must use adequate contraception No reaction or intolerance to ACE inhibitors PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 year since prior cumulative anthracycline therapy of at least 200 mg/m2 No prior amsacrine therapy Endocrine therapy: Not specified Radiotherapy: No prior mediastinal, spinal, or total body irradiation that included the heart Surgery: Not specified Other: No concurrent angiotensin converting enzyme (ACE)inhibitor treatment No concurrent treatment with other investigational drug No oncologic therapy within past 6 months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

8 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment

Group II

Experimental
< 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment

Group III

Experimental
>= 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment

Group IV

Experimental
>= 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment

Group 5

Experimental
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment

Group 6

Experimental
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment

Group 7

Experimental
>= 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment

Group 8

Experimental
>= 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 61 locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

MBCCOP - Gulf Coast

Mobile, United States

University of Arkansas for Medical Sciences

Little Rock, United States

University of California San Diego Cancer Center

La Jolla, United States
Completed61 Study Centers