Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

• ClinicalTrials.gov Identifier: NCT01071473
• Recruitment Status: Completed
• First Posted: February 19, 2010
• Last Update Posted: February 10, 2014
• Sponsor: St. Jude Children's Research Hospital
• Information provided by (Responsible Party): St. Jude Children's Research Hospital

Tracking Information

• First Submitted Date: February 17, 2010
• First Posted Date: February 19, 2010
• Last Update Posted Date: February 10, 2014
• Study Start Date: February 2010
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 18, 2010): The primary aim of this proposal is to evaluate the feasibility of a 12-week exercise intervention among survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy. [ Time Frame: 12 Weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
• Official Title: Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

Brief Summary

This application proposes a prospective, single arm feasibility clinical trial of a 12-week period of combined endurance and resistance training in survivors of childhood cancer who were treated with doxorubicin and/or daunorubicin and have impaired cardiac function.

Baseline and post intervention imaging, laboratory, and neuropsychological evaluations will be used to determine the effects of the intervention on body composition, serum lipid profile, exercise tolerance, and neurocognitive functioning. Participants will be called weekly to monitor compliance with the intervention. Incentives will be given at intervals during the trial to optimize compliance with the intervention.

Detailed Description

This study will evaluate the feasibility of a 12-week exercise intervention on the cardiac function of survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy.

As a secondary objective, the study will document the effect of a 12-week exercise intervention on exercise tolerance, as determined by measurement of peak VO2 and peak exercise workload, shortening fraction, ejection fraction, and left ventricular wall thickness, and assess the impact of the intervention on neurocognitive functioning in survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Cardiomyopathy

Intervention

Other: 12 Week Exercise Intervention

Trial of a 12-week period of combined endurance and resistance training in survivors of childhood cancer who were treated with doxorubicin and/or daunorubicin and have impaired cardiac function.

Study Arms

Exercise Group

Survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy will participate in a 12 week exercise intervention.

Intervention: Other: 12 Week Exercise Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 6, 2014): 22
• Original Estimated Enrollment (submitted: February 18, 2010): 15
• Actual Study Completion Date: October 2012
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Treated at St. Jude Children's Research Hospital (SJCRH)
• Ages 0 - 17 years at time of treatment
• Treated for any type of cancer
• ≥ 10 years from date of diagnosis
• ≥ 2 years after completion of active cancer therapy
• ≥ 18 years of age
• Treated with doxorubicin and/or daunorubicin (any cumulative dose)
• Ejection fraction of < 55% without medications
• Does not currently meet the Centers for Disease Control (CDC) recommendations for exercise for adults

Exclusion Criteria:

• Ejection fraction ≤ 40%
• Pregnant females (Positive Urine pregnancy Test).
• History of congenital heart disease
• History of myocardial infarction
• History of acute coronary syndrome
• Individuals with pacemakers or implanted defibrillators
• History of radiation therapy that included any part of the heart
• ≥1-mm J-point depression (depression measured 80 msec after J-point) with ST segment flat or down-sloping in the majority of complexes in any ECG lead except AVR with exercise testing.
• All patients will be classified using the recommendations of the American Heart Association. Patients found to be in Class A, C or Class D will not be eligible for study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01071473
• Other Study ID Numbers: CARHAB
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: St. Jude Children's Research Hospital
• Study Sponsor: St. Jude Children's Research Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daniel Green, MD; St. Jude Children's Research Hospital

• PRS Account: St. Jude Children's Research Hospital
• Verification Date: February 2014