LLLT for BCRL: a Randomized, Placebo-controlled Study
ConditionBreast Cancer Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Metastatic cancer(stage IV)
Pregnancy
Presence of other extremity lymphedema (primary or secondary)
History of deep vein thrombosis
Trial design
Treatments tested in this trial
- Large-area low-level laser therapy(Venusure)
- Conventional low-level laser therapy
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov