Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00336089
• Other study ID #: CDR0000466676
• Secondary ID: CSU-GCC-161
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2006
• Last updated: September 16, 2013
• Start date: January 2006

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer Survivor
• Fatigue
• Pain

Intervention

Behavioral:
• exercise intervention

Other:
• educational intervention

Procedure:
• complementary or alternative medicine procedure

• fatigue assessment and management

• management of therapy complications

• pain therapy

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Clayton State University	Morrow	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Clayton State University

Country where clinical trial is conducted

United States,