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Aerobic Exercise in Patients Receiving Chemotherapy for Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008
Sponsors and Collaborators: Wake Forest University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00728429
  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
Cancer-Related Problem/Condition
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: cardiotoxicity attenuation
Procedure: exercise intervention
Procedure: management of therapy complications
Procedure: systemic chemotherapy

MedlinePlus related topics: Cancer Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized
Official Title: CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients enrolling in the study [ Designated as safety issue: No ]
  • Percentage of patients completing the study [ Designated as safety issue: No ]
  • Number and types of adverse events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • V02 peak before and after chemotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: June 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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 Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Gretchen Wells, MD, PhD Wake Forest University
Principal Investigator: Peter H. Brubaker, PhD Wake Forest University
  More Information

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

Responsible Party: Wake Forest University Comprehensive Cancer Center ( Gretchen Wells )
Study ID Numbers: CDR0000601334, CCCWFU-99108, CCCWFU-IRB-IRB00006209
Study First Received: August 2, 2008
Last Updated: October 17, 2008
ClinicalTrials.gov Identifier: NCT00728429  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
cardiac toxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on January 13, 2009