Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
- Conditions
- Unspecified Childhood Solid Tumor, Protocol SpecificCardiac Toxicity
- Interventions
- Procedure: quality-of-life assessment
- Registration Number
- NCT00003070
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells from the toxic effects of chemotherapy. It is not known whether enalapril is more effective than a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of enalapril with a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stratum 1 < 350/mg/m2 anthracycline dose quality-of-life assessment \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 2 < 350mg/m2 anthracycline dose quality-of-life assessment \< 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 5 >= 350mg/m2 anthracycline dose enalapril maleate \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 8 >= 350mg/m2 anthracycline dose quality-of-life assessment \>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 2 < 350mg/m2 anthracycline dose enalapril maleate \< 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 3 < 350mg/m2 anthracycline dose quality-of-life assessment \>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 4 < 350mg/m2 anthracycline dose quality-of-life assessment \>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 5 >= 350mg/m2 anthracycline dose quality-of-life assessment \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 6 >=350mg/m2 anthracycline dose quality-of-life assessment \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 7 >= 350mg/m2 anthracycline dose quality-of-life assessment \>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 4 < 350mg/m2 anthracycline dose enalapril maleate \>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 1 < 350/mg/m2 anthracycline dose enalapril maleate \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 3 < 350mg/m2 anthracycline dose enalapril maleate \>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 6 >=350mg/m2 anthracycline dose enalapril maleate \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 7 >= 350mg/m2 anthracycline dose enalapril maleate \>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 8 >= 350mg/m2 anthracycline dose enalapril maleate \>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment
- Primary Outcome Measures
Name Time Method Cardiac functional status and quality of life baseline, two and five years Cardiac functional status (depressed fractional shortening) and quality-of-life, will be assessed at baseline, two and five years into the study.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (61)
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
Scroll for more (51 remaining)University of Alabama at Birmingham Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States