Low Level Laser Treatment and Breast Cancer Related Lymphedema
Completed · Phase 4
Conditions studied: Lymphedema
In brief
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 Laser Therapy (LLLT) was approved in 2006 by the FDA for professional and self/home treatment of lymphedema. LLLT is being offered as a treatment option in many lymphedema treatment settings, but there are few studies of the effectiveness of LLLT as a stand-alone lymphedema treatment or as a possible complementary lymphedema treatment modality to Manual Lymphatic Drainage. The objective 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 quality of life (QOL) in breast cancer survivors with lymphedema. Findings from this pilot study will be used to determine if LLLT has possible value in the treatment of lymphedema and warrants subsequent evaluation in a larger study.
Key facts
- Study ID
- NCT00852930
- Run by
- Vanderbilt University
- People needed
- 50
- Starts
- 2009-09-01
- Expected to finish
- 2012-04-01
- Last updated by the study team
- 2017-04-11
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Vanderbilt University School of Nursing — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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