CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study
18 Years
80 Years
Both
Cardiac Toxicity, Chemotherapeutic Agent Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study
OBJECTIVES:
- To determine if patients with cancer can exercise safely and routinely, under
supervision, while receiving anthracycline chemotherapy.
- To determine the magnitude of the change in the peak ventilatory oxygen uptake (VO2)
before and after completion of anthracycline chemotherapy with concurrent exercise
versus without exercise in patients with cancer.
OUTLINE: Patients are randomized to 1 of 2 intervention arms.
- Arm I (exercise): Patients undergo supervised aerobic exercise (walk or bicycle) 3 days
a week concurrently with standard anthracycline-based chemotherapy for approximately
18-24 weeks.
- Arm II (non-exercise): Patients receive standard anthracycline-based chemotherapy for
approximately 18-24 weeks.
Patients undergo peak ventilatory oxygen uptake (VO_2) by exercise bike test with gas
exchange analysis at baseline and at 2 weeks after completion of anthracycline-based
chemotherapy.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Patients with cancer scheduled to receive 4-6 courses of an anthracycline-based
chemotherapy
PATIENT CHARACTERISTICS:
- Able to pedal a stationary bicycle
- No severe hypertension (systolic blood pressure > 220 mm Hg or diastolic blood
pressure >120 mm Hg)
- No atrial fibrillation with an uncontrolled ventricular response
- No ventricular arrhythmias
- No unstable angina
- No acute myocardial infarction within the past 28 days of enrollment
- No severe valvular heart disease
- No severe (exercise-limiting) peripheral vascular disease
- No severe pulmonary disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Percentage of patients enrolling in the study
Outcome Time Frame:
day 1
Safety Issue:
No
Principal Investigator
Gretchen Wells, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Comprehensive Cancer Center of Wake Forest University
Authority:
United States: Institutional Review Board
Study ID:
CDR0000601334
NCT ID:
NCT00728429
Start Date:
June 2008
Completion Date:
May 2009
Related Keywords:
- Cardiac Toxicity
- Chemotherapeutic Agent Toxicity
- Unspecified Adult Solid Tumor, Protocol Specific
- cardiac toxicity
- chemotherapeutic agent toxicity
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
