NCT00852930

Low Level Laser Treatment and Breast Cancer Related Lymphedema

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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 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.

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 quality of life (QOL) in breast cancer survivors with related LE. Findings from this pilot randomized study will be used to determine if LLLT has possible value in the treatment of LE and warrants subsequent evaluation in a larger study.

Conditions

• Lymphedema

Interventions

Type	Name	Description
PROCEDURE	laser and MLD combined	The intervention is therapist administered laser and mld treatment combined
PROCEDURE	laser alone	The intervention is therapist administered laser
PROCEDURE	manual lymphatic drainage	The intervention is therapist administered manual lymphatic drainage

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2009-02-27
• Last updated: 2017-04-11
• Results posted: 2015-11-02

Locations

1 site across 1 country: United States