Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00728429
• Other study ID #: CDR0000601334
• Secondary ID: CCCWFU-99108CCCW
• Status: Terminated
• Phase: N/A
• First received: August 2, 2008
• Last updated: May 25, 2017
• Start date: June 2008
• Est. completion date: May 2009

Study information

• Verified date: February 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• exercise intervention
24 week program of exercise

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients enrolling in the study		day 1
Primary	Percentage of patients completing the study		24 weeks
Primary	V02 peak before and after chemotherapy		24 weeks