Status:
COMPLETED
Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Tactile Systems Technology, Inc.
Conditions:
Arm Lymphedema
Truncal Lymphedema
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
No studies have tested the potential benefit of the Flexitouch® truncal/chest garments on reducing truncal lymphedema in breast cancer survivors (BCS) or the theoretical added benefit of applying trun...
Detailed Description
Screening Procedures This study will have a three-phase screening process. Phase One: Participants will be screened either in person or via the telephone. Phase Two: If the person being interviewe...
Eligibility Criteria
Inclusion
- Individuals at least six months post- surgery and/or radiation treatment for breast cancer
- At least 21 years of age
- Lymphedema in one arm subsequent to breast cancer treatment with coexisting truncal swelling \*\* (Part One) and \*lymphedema in one arm subsequent to breast cancer treatment without coexisting truncal swelling (Part Two)
- Willing and able to drive to the study site as needed
- Currently not using a compression pump or undergoing manual lymphatic drainage by a therapist
Exclusion
- Actively undergoing or less than six months post intravenous chemotherapy or radiation therapy
- Individuals with congestive heart failure, chronic/acute renal disease, cor pulmonal, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, thrombophlebitis, deep vein thrombosis, infection of any kind and inflammation (redness) in the trunk or arms
- History of bilateral breast cancer
- Metastatic cancer
- Inability to stand upright
- Metal implants that would interfere with bioimpedance measurement equipment
- Pregnancy
- Pacemaker and internally implanted defibrillators
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00880022
Start Date
May 1 2009
End Date
May 1 2010
Last Update
December 5 2017
Active Locations (1)
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1
Vanderbilt Univeristy
Nashville, Tennessee, United States, 37240