LLLT for BCRL: a Randomized, Placebo-controlled Study
Breast Cancer Lymphedema
About this trial
This is an interventional treatment trial for Breast Cancer Lymphedema focused on measuring Breast Cancer Lymphedema, Lymphedema, Breast cancer, Low level laser therapy
Eligibility Criteria
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 segment Able to commit to a long-term follow-up schedule Exclusion Criteria: Metastatic cancer(stage IV) Pregnancy Presence of other extremity lymphedema (primary or secondary) History of deep vein thrombosis Pacemaker Artificial joints, implant or tattoo(area≥4 cm2) at the involved upper extremity Previous 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Large-area low-level laser therapy
Conventional low-level laser therapy
Large-area low-level laser therapy(Venusure) was administered at proximal forearm, upper arm and axillary region of affected side. The wavelength was 980±15nm, average dose was 10-40nm/cm2 and maximal output was 1000mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks.
Conventional low-level laser therapy was administrated on antecubital fossa and the axilla of affected side. The wavelength was 808nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks.