LLLT for BCRL: a Randomized, Placebo-controlled Study
Recruiting · NCT05725265 · Interventional (participants receive a specific treatment) · Lead sponsor: National Taiwan University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Conventional low-level laser therapyLarge-area low-level laser therapy(Venusure)
What this trial is about
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.
Who can take part
Age range
20 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed.
- National Taiwan University Hospital - Taipei, Taiwan