Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00728429
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Toxicity; Chemotherapeutic Agent Toxicity; Unspecified Adult Solid Tumor, Protocol Specific	Behavioral: exercise intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• 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
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: standard of care normal anthracycline therapy
Experimental: exercise program	Behavioral: exercise intervention; 24 week program of exercise

Outcome Measures

Primary Outcome Measures

1. Percentage of patients enrolling in the study [day 1]

2. Percentage of patients completing the study [24 weeks]

3. V02 peak before and after chemotherapy [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00728429
• Other Study ID Numbers: CDR0000601334; CCCWFU-99108; CCCWFU-IRB-IRB00006209
• First Posted: Aug 5, 2008
• Last Update Posted: May 30, 2017
• Last Verified: Feb 1, 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

Study Results

No Results Posted as of May 30, 2017