Clinical trial NCT00728429: Aerobic Exercise in Patients Receiving Chemotherapy for Cancer
Official title: CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Toxicity
Chemotherapeutic Agent Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: cardiac toxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-08-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients enrolling in the study
timeFrame: day 1
measure: Percentage of patients completing the study
timeFrame: 24 weeks
measure: V02 peak before and after chemotherapy
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gretchen Wells, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Peter H. Brubaker, PhD
role: PRINCIPAL_INVESTIGATOR
References: