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Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00728429
First Posted: August 5, 2008
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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
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

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728429


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

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00728429     History of Changes
Other Study ID Numbers: CDR0000601334
CCCWFU-99108
CCCWFU-IRB-IRB00006209
First Submitted: August 2, 2008
First Posted: August 5, 2008
Last Update Posted: May 30, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
cardiac toxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries