Low-level laser therapy for breast cancer-related lymphedema
Large-area Low-level Laser Therapy for Breast Cancer-related Lymphedema: a Randomized, Placebo-controlled Study
This study is testing whether a larger area of low-level laser therapy can help women with breast cancer-related swelling in their arms feel better compared to standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05725265 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of large-area versus conventional low-level laser therapy (LLLT) in treating breast cancer-related lymphedema (BCRL) following mastectomy. It aims to measure changes in the severity of lymphedema through circumference and skin thickness assessments using ultrasound, while also evaluating clinical symptoms such as pain, shoulder mobility, and hand function. The study targets female patients with unilateral BCRL and will monitor their progress over time to determine the best therapeutic approach.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 20 and older with unilateral breast cancer who have undergone lumpectomy or mastectomy and lymph node dissection, and who exhibit stage I or II lymphedema.
Not a fit: Patients with metastatic cancer, pregnancy, or other conditions that could complicate lymphedema treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate symptoms and improve the quality of life for patients suffering from breast cancer-related lymphedema.
How similar studies have performed: Previous studies have shown promising results with low-level laser therapy for lymphedema, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Ying-Chun Chen, MD
- Email: yasandy2000@gmail.com
- Phone: 23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.