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Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00728429
Enrollment
1
Registered
2008-08-05
Start date
2008-06-30
Completion date
2009-05-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cardiac toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific

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.

Interventions

BEHAVIORALexercise intervention

24 week program of exercise

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Percentage of patients enrolling in the studyday 1
Percentage of patients completing the study24 weeks
V02 peak before and after chemotherapy24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026