CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- V02 peak before and after chemotherapy
Study Overview
Brief Summary
RATIONALE: Aerobic exercise may help prevent side effects caused by chemotherapy and help improve heart health.
PURPOSE: This randomized clinical trial is studying the side effects of aerobic exercise and to see how well it works in patients receiving chemotherapy for cancer.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
standard of care
normal anthracycline therapy
exercise program
Intervention: exercise intervention (Behavioral)
Outcomes
Primary Outcomes
V02 peak before and after chemotherapy
Time Frame: 24 weeks
Percentage of patients enrolling in the study
Time Frame: day 1
Percentage of patients completing the study
Time Frame: 24 weeks
Secondary Outcomes
No secondary outcomes reported