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Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

Primary Purpose

Cardiac Toxicity, Chemotherapeutic Agent Toxicity, Unspecified Adult Solid Tumor, Protocol Specific

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise intervention
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Toxicity focused on measuring cardiac toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard of care

exercise program

Arm Description

normal anthracycline therapy

Outcomes

Primary Outcome Measures

Percentage of patients enrolling in the study
Percentage of patients completing the study
V02 peak before and after chemotherapy

Secondary Outcome Measures

Full Information

First Posted
August 2, 2008
Last Updated
May 25, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00728429
Brief Title
Aerobic Exercise in Patients Receiving Chemotherapy for Cancer
Official Title
CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Toxicity, Chemotherapeutic Agent Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
cardiac toxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard of care
Arm Type
No Intervention
Arm Description
normal anthracycline therapy
Arm Title
exercise program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Intervention Description
24 week program of exercise
Primary Outcome Measure Information:
Title
Percentage of patients enrolling in the study
Time Frame
day 1
Title
Percentage of patients completing the study
Time Frame
24 weeks
Title
V02 peak before and after chemotherapy
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Wells, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter H. Brubaker, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

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Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

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