Breast Cancer Patients: A Breast Cancer Rehabilitation and Exercise Laboratory
|ClinicalTrials.gov Identifier: NCT01157130|
Recruitment Status : Unknown
Verified July 2011 by Nevada Cancer Institute.
Recruitment status was: Recruiting
First Posted : July 5, 2010
Last Update Posted : July 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Early Stage Breast Cancer (Stage 0-III)||Other: Exercise Regimen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory|
|Study Start Date :||July 2010|
Experimental: Intervention Group
Each patient will have a weekly goal of 2000 calories burned and 18 MET-hours of exercise which can be achieved in 4 to 7 hours of physical activity per week. Resistance training, using weight machines and aerobic training using treadmills, elliptical trainers and stationary bicycles, will be utilized in the intervention group.
Other: Exercise Regimen
No Intervention: Control Group
The control group will receive basic information on physical activity but not be instructed.
- Changes in CRPThe primary endpoint for this study change in C-reactive protein.
- Change in laboratory values
Compare changes in:
- Change in body compositionBody composition parameters and bone density will be assessed using Dual Energy X-ray Absorptiometry (DEXA) and compared between the two groups.
- Quality of LifeQuality of Life will be measured and compared between the groups
- Overall SurvivalComparing overall survival and progression free survival between groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157130
|United States, Nevada|
|Nevada Cancer Institute||Recruiting|
|Las Vegas, Nevada, United States, 89135|
|Contact: Breanne Eddington 702-821-0062 firstname.lastname@example.org|
|Contact: Karen Milligan, MD 702-822-5433|
|Principal Investigator: Karen Milligan, MD|
|Principal Investigator:||Karen Milligan, MD||Nevada Cancer Institute|