LLLT for BCRL: a Randomized, Placebo-controlled Study

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Feb 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how effective low-level laser therapy (LLLT) is in treating breast cancer-related lymphedema, which is swelling that can occur in the arm after breast surgery. The study will compare two different sizes of laser treatment areas to see which one works better in reducing swelling. Researchers will measure changes in the severity of lymphedema by looking at the size and thickness of the arm using ultrasound, as well as assessing any pain, shoulder movement, and hand function that participants may experience.

To be eligible for this study, participants need to be women aged 20 or older who have had breast cancer surgery and are experiencing swelling in one arm. They should have a noticeable difference in arm size compared to the other arm and be willing to attend follow-up appointments over a long period. However, certain conditions, like having advanced cancer or other health issues, will disqualify some individuals from participating. If eligible, participants can expect to receive either the laser treatment or a placebo (a treatment with no active effect) and will be monitored for changes in their symptoms and arm measurements throughout the trial.

Gender

FEMALE

Eligibility criteria

• 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)