Breast Cancer Clinical Trial
Official title:
The Effects of Combined Strength Training and Functional Endurance Exercise Regimen on Cancer-Related Fatigue and Physical Performance
Verified date | July 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Primary Objective:
-Determine if a specific exercise regimen (combined strength training/functional endurance)
reduces the level of fatigue among women with breast cancer while undergoing adjuvant or
neoadjuvant chemotherapy treatment as compared to a control group.
Secondary Objectives:
- Determine if a specific exercise regimen (combined strength training/functional
endurance) increases the overall ability to perform daily physical activities (ADLs)
among women with breast cancer while undergoing adjuvant or neoadjuvant chemotherapy
treatment as compared to a control group.
- Determine if a specific exercise regimen (combined strength training/ functional
endurance) increases mobility in women with breast cancer while undergoing adjuvant or
neoadjuvant chemotherapy treatment as compared to a control group.
- Determine if a specific exercise regimen (combined strength training/functional
endurance) increases endurance in women with breast cancer while undergoing adjuvant or
neoadjuvant chemotherapy as compared to a control group.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Subjects must have a clinical diagnosis of breast cancer (Stages I - III), 2. be between the ages of 21 and 60 years; 3. may have undergone definitive surgical procedure (lumpectomy or mastectomy), and 4. be scheduled to receive any chemotherapy/hormonal blocker regimen that is appropriate for treatment of breast cancer (neoadjuvant or adjuvant) 5. approval of the Oncologist responsible for overseeing the cancer treatment plan for the patient to participate in this study. Exclusion Criteria: 1. Exclusion criteria include presence of concomitant major health problems in which an exercise regimen is contraindicated (e.g. cardiac, pulmonary, and orthopedic) 2. Currently participating in a structured exercise program which is defined as a regular walking, stretching, and or dance type exercise that is performed at least 30 minutes or greater each time and more than 3 times per week. 3. Women who have had breast reconstructive surgery. 4. Men diagnosed with breast cancer. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | U.T. M.D. Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Fatigue Scores | Self-reported score that measures subjective perceptions of fatigue in which respondents rate their experience of feeling tired. It ranges from 1 (not at all) to 5 (extremely) and describes discomforts of cancer related fatigue in four dimensions (physical, mental, emotional, and temporal) (Schwartz and Meek, 1999). | Approximately 6 months | No |
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