Aerobic Exercise in Patients Receiving Chemotherapy for Cancer
|ClinicalTrials.gov Identifier: NCT00728429|
Recruitment Status : Terminated (slow accrual)
First Posted : August 5, 2008
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Toxicity Chemotherapeutic Agent Toxicity Unspecified Adult Solid Tumor, Protocol Specific||Behavioral: exercise intervention||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
No Intervention: standard of care
normal anthracycline therapy
|Experimental: exercise program||
Behavioral: exercise intervention
24 week program of exercise
- Percentage of patients enrolling in the study [ Time Frame: day 1 ]
- Percentage of patients completing the study [ Time Frame: 24 weeks ]
- V02 peak before and after chemotherapy [ Time Frame: 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728429
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Gretchen Wells, MD, PhD||Wake Forest University Health Sciences|
|Principal Investigator:||Peter H. Brubaker, PhD||Wake Forest University Health Sciences|