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LLLT for BCRL: a Randomized, Placebo-controlled Study

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.

ClinicalTrials.gov IDNCT05725265

PhaseNA

Enrollment54

SponsorNational Taiwan University Hospital

Age20 Years

SexFEMALE

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Conditions studied

Breast Cancer Lymphedema

About this study

Interventions

Device: Large-area low-level laser therapy(Venusure) — 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
Device: Conventional low-level laser therapy — 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.

Primary outcomes

Circumference discrepancy of bilateral upper arm (Day 30 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section)
Circumference discrepancy of bilateral upper arm (Day 60 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section)
Circumference discrepancy of bilateral upper arm (Day 120 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section)

Eligibility information

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)

Study locations

National Taiwan University Hospital, Taipei, Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.