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Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01071473
First received: February 17, 2010
Last updated: October 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Cardiomyopathy
 Other: 12 Week Exercise Intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercise Group
Survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy will participate in a 12 week exercise 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071473

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Daniel Green, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
St. Jude Children's Research Hospital  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01071473     History of Changes
Other Study ID Numbers: CARHAB
Study First Received: February 17, 2010
Last Updated: October 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Childhood cancer
Anthracyclines
Cardiomyopathy

Additional relevant MeSH terms:
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013