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Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
This study is currently recruiting participants.
Study NCT00336089   Information provided by National Cancer Institute (NCI)
First Received: June 8, 2006   Last Updated: February 6, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

June 8, 2006
February 6, 2009
January 2006
 
 
Complete list of historical versions of study NCT00336089 on ClinicalTrials.gov Archive Site
 
 
 
Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors

RATIONALE: An exercise program or health education program may help relieve fatigue and pain and improve the quality of life in women who are breast cancer survivors. It is not yet known whether an exercise program is more effective than a health education program or no program in reducing fatigue and pain in women who are breast cancer survivors.

PURPOSE: This randomized clinical trial is studying an exercise program to see how well it works in reducing fatigue and pain compared to a health education program or no program in women who are breast cancer survivors.

OBJECTIVES:

  • Determine whether a moderate-intensity exercise program comprising cardiorespiratory and resistance training of the legs, back, abdominal, trunk, and arm musculature vs a control group attenuates fatigue and pain in breast cancer survivors.
  • Determine whether this exercise program will significantly improve the quality of life of these patients.
  • Determine whether this exercise program can significantly reduce the number of days of absenteeism from work in these patients.
  • Determine whether this exercise program can significantly attenuate mood disturbances in these patients.

OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (exercise program): Patients participate in an exercise program comprising cardiorespiratory (walking on a treadmill) and resistance training for 1 hour, 3 times weekly for 12 weeks.
  • Arm II (control): Patients undergo no intervention. In both arms, patients complete questionnaires regarding general health, mood, work attendance, and physical activity before the start of study treatment and then every 3 weeks for 12 weeks. Patients also complete a 7-day physical activity diary and sleep diary every 3 weeks.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

 
Interventional
Other, Randomized, Active Control
  • Breast Cancer
  • Fatigue
  • Pain
  • Behavioral: exercise intervention
  • Other: educational intervention
  • Procedure: complementary or alternative medicine procedure
  • Procedure: fatigue assessment and management
  • Procedure: management of therapy complications
  • Procedure: pain therapy
  • Procedure: quality-of-life assessment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
54
 
December 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Breast cancer survivor
  • Received adjuvant chemotherapy or radiotherapy for breast cancer only

    • Must have completed treatment 2-6 months ago
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Hemoglobin ≥ 11 g/dL
  • Able to read English
  • No high-risk for cardiovascular problems during exercise, including any of the following:

    • Unstable heart disease
    • Unstable angina
    • Chronic respiratory disease
    • Dizziness
    • Uncontrolled hypertension
  • No severe respiratory disease requiring oxygen therapy
  • No history of anorexia (body mass index [BMI] < 18.5) or severe obesity (BMI > 35)
  • No history of multiple cancers
  • No shortness of breath or hypotension
  • No sudden swelling of the ankles, hands or face
  • No palpitations or arrhythmias
  • No persistent and intolerable pain
  • No major acute illness (e.g., fever or respiratory infection)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years to 60 Years
No
 
United States
 
 
NCT00336089
 
CSU-GCC-161
Clayton State University
 
Study Chair: Melanie Poudevigne, PhD Clayton State University
National Cancer Institute (NCI)
March 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.