Aerobic Exercise in Patients Receiving Chemotherapy for Cancer

NCT00728429 | Terminated

• 3 other identifiers: CDR0000601334CCCWFU-99108CCCWFU-IRB-IRB00006209
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cardiac toxicity; chemotherapeutic agent toxicity; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (3)

• Percentage of patients enrolling in the study

  day 1

• Percentage of patients completing the study

  24 weeks

• V02 peak before and after chemotherapy

  24 weeks

Study Arms (2)

standard of care

NO INTERVENTION

normal anthracycline therapy

exercise program

EXPERIMENTAL

Behavioral: exercise intervention

Interventions

exercise intervention BEHAVIORAL

24 week program of exercise

exercise program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Gretchen Wells, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Peter H. Brubaker, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2008
• First Posted: August 5, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 30, 2017

Record last verified: 2017-02

Locations

US (1)