Lymphedema
Conditions
Keywords
Lymphedema, Breast Cancer, Upper Extremity, Arm
Brief summary
The purpose of this study is to determine how well different treatments for acquired lymphedema work. The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.
Detailed description
This study will compare 5 non-invasive lymphedema treatments. Patients will be assigned to either: \- A combination of arm exercises, arm elevation, and wearing of a compression garment every day OR \- One of four possible pneumatic compression devices for just two hours every day. Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken. None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home. The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.
Interventions
OTHERExercise, Elevation, and Compression Garment
Patients will be asked to daily: * exercise * elevate arm * wear an arm compression garment
DEVICEE0650 PCD with non-sequential waveform
Use of an E0650 PCD with non-sequential waveform for two hours every day.
DEVICEE0651 PCD with sequential, non-gradient waveform
Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day
DEVICEE0652 PCD with sequential, gradient waveform
Use of an E0652 PCD with sequential, gradient waveform for two hours every day.
DEVICEE0652 PCD with peristaltic pulse waveform
Use the E0652 PCD with peristaltic pulse waveform for two hours every day.
Sponsors
NormaTec Industries LP
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with acquired lymphedema of the arm.
Exclusion criteria
* Refusal of consent * Unlikely compliance with the research protocol * Acute upper extremity DVT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arm Volume | Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts |
Secondary
| Measure | Time frame |
|---|---|
| Infection (cellulitis) | Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts |
| Quality of Life Survey | Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts |
Countries
United States
Outcome results
None listed