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Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema


N/A
18 Years
N/A
Not Enrolling
Both
Lymphedema

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Trial Information

Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Arm Volume

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Arin K Greene, MD, MMSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Boston

Authority:

United States: Institutional Review Board

Study ID:

AQ-UE-LYMPHEDMA-PCD-RCT

NCT ID:

NCT00951067

Start Date:

August 2009

Completion Date:

August 2011

Related Keywords:

  • Lymphedema
  • Lymphedema
  • Breast Cancer
  • Upper Extremity
  • Arm
  • Lymphedema

Name

Location

Children's Hospital Boston at WalthamWaltham, Massachusetts  02453