Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors - Full Text View

Sponsored by:	Clayton State University
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00336089

Purpose

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.

Condition	Intervention
Breast Cancer Fatigue Pain	Procedure: complementary or alternative medicine procedure Procedure: educational intervention Procedure: exercise intervention Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: pain therapy Procedure: quality-of-life assessment

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	54
Study Start Date:	January 2006
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336089

Locations

United States, Georgia
Clayton State University	Recruiting
Morrow, Georgia, United States, 30260-0285
Contact: Melanie Poudevigne, PhD 678-466-4937 mpoudevigne@clayton.edu
Saint Joseph's Hospital of Atlanta	Recruiting
Atlanta, Georgia, United States, 30342-1701
Contact: Clinical Trials Office - Saint Joseph's Hospital of Atlanta 404-851-7115

Sponsors and Collaborators

Clayton State University

Investigators

Study Chair:

Melanie Poudevigne, PhD

Clayton State University

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000466676, CSU-GCC-161
Study First Received:	June 8, 2006
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00336089
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fatigue
pain
breast cancer in situ
inflammatory breast cancer
stage I 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

Study placed in the following topic categories:

Signs and Symptoms
Inflammatory breast cancer
Fatigue
Skin Diseases

Breast Neoplasms
Pain
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009