NCT01157767CompletedNot Applicable
A Feasibility Study of the Effects of a Directed Exercise Program of Breast Cancer Patients Undergoing Chemotherapy With or Without Radiation
Memorial Sloan Kettering Cancer Center1 site in 1 country90 target enrollmentStarted: May 11, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To evaluate compliance with and demonstrate the feasibility of an at-home, directed exercise program during adjuvant chemotherapy and radiation (if applicable).
Study Overview
Brief Summary
The purpose of this study is to study if a patients follows an exercise program specifically designed for them during the time of their treatment after surgery. Their ability to follow the program and its influence on their weight maintenance and early post-operative lymphedema rates will also be studied. Lymphedema is a condition in which excess fluid collects in tissue and causes swelling of the arm(s).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients will be eligible if they have any of the following surgical procedures performed by an attending on the Breast Service:
- •SLNB alone Axillary lymph node dissection (ALND) alone Total Mastectomy TM (+/- reconstruction) with SLNB or ALND Breast conserving therapy (BCT) with SLNB or ALND
- •Age > 18 years
- •Planned to undergo adjuvant post-operative chemotherapy with or without radiation at MSKCC and have not yet started chemotherapy
Exclusion Criteria
- •Undergoing TM or BCT without SLNB
- •Having had prior breast cancer treated with surgery
- •Unable to participate in a exercise program related to other medical problems
- •More than 8 weeks post surgery.
- •Having a concurrent cancer in addition to breast cancer
- •Who have had any type of chemotherapy in the past two years
Outcomes
Primary Outcomes
To evaluate compliance with and demonstrate the feasibility of an at-home, directed exercise program during adjuvant chemotherapy and radiation (if applicable).
Time Frame: 2 years
Secondary Outcomes
- To describe how this exercise program affects weight maintenance and percent body fat during adjuvant chemotherapy and radiation.(2 years)
- To describe how this exercise program affects early post-operative lymphedema rates, monitoring the strength training specifics -including the number of repetitions and sets of each exercise, frequency, and order of exercises.(2 years)
Investigators
Study Sites (1)
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