LLLT for BCRL: a Randomized, Placebo-controlled Study

This study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema. The change of severity of BCRL will be measured by the difference of circumference and skin thickness, detected by ultrasound. The influence on clinical symptoms, such as pain, shoulder mobility and hand function, are also investigated in the study.

Inclusion Criteria:Female subjects, 20 years age or older, suffered from unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)Stage I or II unilateral secondary upper extremity lymphedema(as defined by the International Society of Lymphology)Girth≥ 2 cm circumferential difference compared with the uninvolved upper extremity at any 4 cm segmentAble to commit to a long-term follow-up scheduleExclusion Criteria:Metastatic cancer(stage IV)PregnancyPresence of other extremity lymphedema (primary or secondary)History of deep vein thrombosisPacemakerArtificial joints, implant or tattoo(area≥4 cm2) at the involved upper extremityPrevious treatment with low-level laser therapy (within 3 months)Body mass index (BMI) > 35 (morbid obesity)High bleeding tendency(hemophilia)Receiving long-term steroid treatment (oral or systemic)