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LLLT for BCRL: a Randomized, Placebo-controlled Study

RecruitingNAAges 20 Years - anyFemaleNational Taiwan University Hospital
NCT05725265 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Large-area low-level laser therapy(Venusure)
  • Conventional low-level laser therapy
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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