Clinical trial NCT00336089: Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
Official title: The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Cancer Survivor
Fatigue
Pain
Keywords: fatigue
pain
cancer survivor
breast cancer in situ
inflammatory breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-06-12
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Saint Joseph's Hospital of Atlanta
state: Georgia
city: Morrow
country: United States
facility: Clayton State University
state: Georgia
Study officials:
affiliation: Clayton State University
name: Melanie Poudevigne, PhD
role: STUDY_CHAIR
References: