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Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

Primary Purpose

Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12 Week Exercise Intervention
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiomyopathy focused on measuring Childhood cancer, Anthracyclines, Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise Group

Arm Description

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2010
Last Updated
February 6, 2014
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01071473
Brief Title
Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
Official Title
Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy
Keywords
Childhood cancer, Anthracyclines, Cardiomyopathy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Other
Arm Description
Survivors of childhood cancer treated with anthracyclines and known to have cardiomyopathy will participate in a 12 week exercise intervention.
Intervention Type
Other
Intervention Name(s)
12 Week Exercise Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Green, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

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Resistance and Aerobic Exercise for Subclinical Anthracycline Cardiomyopathy

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