Status:
COMPLETED
Low Level Laser Treatment and Breast Cancer Related Lymphedema
Lead Sponsor:
Vanderbilt University
Conditions:
Lymphedema
Eligibility:
FEMALE
21+ years
Phase:
PHASE4
Brief Summary
Manual Lymphatic Drainage (massage therapy) with compression (wearing a tight sleeve on the arm) is the current standard of treatment for breast cancer related lymphedema (arm swelling). Low-Level Las...
Detailed Description
The purpose of this proposed pilot study is to examine the impact of Advance Practice Nurse (ANP) administered LLLT, as both a stand-alone and complementary treatment, on arm volume, symptoms, and qua...
Eligibility Criteria
Inclusion
- Breast cancer survivors will be included if they:
- are age 21 or older;
- require professional treatment for Stage I or II lymphedema as defined by the International Society of Lymphology;
- have an order for lymphedema treatment; and
- are willing and able to drive to the study sites.
Exclusion
- Individuals will not be included if they:
- are actively undergoing intravenous chemotherapy or radiation therapy;
- have a history of bilateral lymphedema that prohibits extracellular fluid comparison to an unaffected limb;
- are unable to stand upright for measurement of height and weight;
- have active/metastatic cancer;
- are pregnant,:
- have artificial joints in areas where electrode placement is critical, or have a pacemaker/internal defibrillator; or
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00852930
Start Date
September 1 2009
End Date
April 1 2012
Last Update
April 11 2017
Active Locations (1)
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1
Vanderbilt University School of Nursing
Nashville, Tennessee, United States, 37240