LLLT for BCRL: a Randomized, Placebo-controlled Study
Large-area Low-level Laser Therapy for Breast Cancer-related Lymphedema: a Randomized, Placebo-controlled Study
National Taiwan University Hospital
54 participants
Oct 24, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria10
- 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)
Interventions
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; for a total of 12 sessions
The wavelength was 808 nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions.
Locations(1)
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NCT05725265