Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

Wake Forest University (WFU)

Status: Terminated

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

Treatments: Behavioral: exercise intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00728429

CDR0000601334

CCCWFU-IRB-IRB00006209

CCCWFU-99108

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

standard of care

No Intervention group

Description:

normal anthracycline therapy

exercise program

Experimental group

Treatment:

Behavioral: exercise intervention