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New treatment option for Breast Cancer Lymphedema
Official title LLLT for BCRL: a Randomized, Placebo-controlled Study
ClinicalTrials.gov ID: NCT05725265
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older, women only
You may be able to join if
- Female people, 20 years age or older, suffered from unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node 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
You likely can't join if
- 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
See the full eligibility criteria
- Female people, 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.