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Low Level Laser Treatment and Breast Cancer Related Lymphedema


Phase 4
21 Years
N/A
Not Enrolling
Female
Lymphedema

Thank you

Trial Information

Low Level Laser Treatment and Breast Cancer Related Lymphedema


Inclusion Criteria:



Breast cancer survivors will be included if they:

1. are age 21 or older;

2. require professional treatment for Stage I or II lymphedema as defined by the
International Society of Lymphology;

3. have an order for lymphedema treatment; and

4. are willing and able to drive to the study sites.

Exclusion Criteria:

Individuals will not be included if they:

1. are actively undergoing intravenous chemotherapy or radiation therapy;

2. have a history of bilateral lymphedema that prohibits extracellular fluid comparison
to an unaffected limb;

3. are unable to stand upright for measurement of height and weight;

4. have active/metastatic cancer;

5. are pregnant,:

6. have artificial joints in areas where electrode placement is critical, or have a
pacemaker/internal defibrillator; or

7. have congestive heart failure (CHF), chronic/acute renal or hepatic disease,
pulmonary edema, thrombophlebitis, deep vein thrombosis (DVT), acute infection of any
kind, and inflammation in the trunk or arms.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Arm volume change

Outcome Time Frame:

Bioeipedance before each treatments and arm circumferences weekly.

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

090118

NCT ID:

NCT00852930

Start Date:

September 2009

Completion Date:

April 2012

Related Keywords:

  • Lymphedema
  • lymphedema
  • quality of life
  • breast cancer
  • symptoms
  • lymphedema in breast cancer survivors
  • Breast Neoplasms
  • Lymphedema

Name

Location

Vanderbilt University School of NursingNashville, Tennessee  37240