Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study

Conditions
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Cardiac Toxicity, Chemotherapeutic Agent Toxicity, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Behavioral: exercise intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard of care<br>normal anthracycline therapy | |
| Experimental: exercise program<br> | Behavioral: exercise intervention<br>* 24 week program of exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients enrolling in the study |  | day 1 | 
| Percentage of patients completing the study |  | 24 weeks | 
| V02 peak before and after chemotherapy |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific