Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer
Completed · Not applicable
Conditions studied: Arm Lymphedema, Truncal Lymphedema, Breast Cancer
In brief
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 truncal/chest pneumatic compression therapy to open lymph channels in individuals who have only limb lymphedema or its impact on the trunk/chest. The purpose of this two-part study is to fill gaps related to: 1) the impact of the Flexitouch® System on truncal lymphedema, and 2) the therapeutic benefit of truncal /chest pneumatic compression therapy for arm lymphedema. Hypotheses: Part One: BCS with arm and truncal lymphedema. H1: Arm swelling (as measured by bioelectrical impedance \& arm girth in cm) will be reduced after 10 sessions with the Flexitouch® System. H2: Truncal swelling (as measured circumferentially) will be reduced after 10 sessions with the Flexitouch® System. H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by the Lymphedema Symptom Intensity and Distress Scale: Trunk and Arm) will be reduced after 10 sessions with the Flexitouch® System. H4: Functional assessment scores (as measured by the Functional Assessment Screening Questionnaire \[FASQ\] will improve after 10 sessions with the Flexitouch® System. Part Two: BCS with Arm Lymphedema H1: Arm volume (as measured by bioelectrical impedance \& arm girth in cm) will be significantly reduced after one month of home use in participants using the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only). H2: Truncal measurements/volume (as measured circumferentially) will be less after one month of home use with the Flexitouch® System (truncal, chest, and arm compression) when compared to those using the Flexitouch® System (arm compression only). H3: The number, severity, and intensity, of physical and psychological symptoms (as measured by Lymphedema Symptom Intensity and Distress Scale - Arm ) will be significantly reduced after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only) . H4: Functional assessment scores (as measured by the FASQ) will be significantly higher after one month of home use with the Flexitouch® System (truncal, chest, and arm garments) when compared to individuals using the Flexitouch® System (arm compression only).
Key facts
- Study ID
- NCT00880022
- Run by
- Vanderbilt University
- People needed
- 47
- Starts
- 2009-05-01
- Expected to finish
- 2010-05-01
- Last updated by the study team
- 2017-12-05
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Vanderbilt Univeristy — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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