Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

Not Applicable

Terminated

• Conditions: Cardiac Toxicity; Chemotherapeutic Agent Toxicity; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Behavioral: exercise intervention

• Registration Number: NCT00728429
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-08-02
• Study First Submitted QC: 2008-08-02
• Study First Posted: 2008-08-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise program	exercise intervention	-

Primary Outcome Measures

Name	Time	Method
V02 peak before and after chemotherapy	24 weeks
Percentage of patients enrolling in the study	day 1
Percentage of patients completing the study	24 weeks

Trial Locations

Locations (1)

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States