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CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study


N/A
18 Years
80 Years
Not Enrolling
Both
Cardiac Toxicity, Chemotherapeutic Agent Toxicity, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

CCCWFU 99108 - Effect of Exercise Training in Patients Receiving Anthracycline Drugs - A Pilot Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Percentage of patients enrolling in the study

Outcome Time Frame:

day 1

Safety Issue:

No

Principal Investigator

Gretchen Wells, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000601334

NCT ID:

NCT00728429

Start Date:

June 2008

Completion Date:

May 2009

Related Keywords:

  • Cardiac Toxicity
  • Chemotherapeutic Agent Toxicity
  • Unspecified Adult Solid Tumor, Protocol Specific
  • cardiac toxicity
  • chemotherapeutic agent toxicity
  • unspecified adult solid tumor, protocol specific

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096