LLLT for BCRL: a Randomized, Placebo-controlled Study

Recruiting now · Not applicable

Conditions studied: Breast Cancer Lymphedema

In brief

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.

Key facts

Study ID: NCT05725265
Run by: National Taiwan University Hospital
People needed: 54
Starts: 2023-10-24
Expected to finish: 2025-10-31
Last updated by the study team: 2024-10-18

Who can join

Age: 20 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

National Taiwan University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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