Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-05-31

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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standard of care

normal anthracycline therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

exercise program

Group Type EXPERIMENTAL

exercise intervention

Intervention Type BEHAVIORAL

24 week program of exercise

Interventions

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exercise intervention

24 week program of exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No