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Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00728429
First received: August 2, 2008
Last updated: July 12, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Cardiac Toxicity
Chemotherapeutic Agent Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
 Behavioral: exercise intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Percentage of patients enrolling in the study [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Percentage of patients completing the study [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • V02 peak before and after chemotherapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard of care
normal anthracycline therapy
Experimental: exercise program Behavioral: exercise intervention
24 week program of exercise

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00728429

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gretchen Wells, MD, PhD Comprehensive Cancer Center of Wake Forest University
Principal Investigator: Peter H. Brubaker, PhD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00728429     History of Changes
Other Study ID Numbers: CDR0000601334, CCCWFU-99108, CCCWFU-IRB-IRB00006209
Study First Received: August 2, 2008
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
cardiac toxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on June 18, 2013