An interventional study of Large-area low-level laser therapy(Venusure) and Conventional low-level laser therapy in Breast Cancer Lymphedema, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
Breast cancer-related lymphedema (BCRL) is common complication after cancer treatment. The incidence of BCRL around is 16.6% (95% CI 13·6-20·2) after the diagnosis and higher among the group receiving the sentinel biopsy or axillary lymph dissection. The lymphedema arises from the accumulation of protein-rich lymph fluid in the interstitial spaces then results in chronic inflammation with symptoms of fibrosis, pain, limited range of motion or paresthesia. The BRCL is chronic and progressive condition, and the severity also changes over time. The definition and cut points of BCRL using inter-limb volume or arm circumference varied across the studies by different measure method. Currently, the International Society of Lymphology suggests calculating arm volume from circumferences through the truncated cone formula to qualify the severity. On the other hand, previous research found the skin and subcutis were thickened in the ipsilateral arm of patients with BCRL. Thus, the measurement of skin thickness using ultrasound may also practical to detect the progression of lymphedema. Except for physical change of upper limb, the symptoms of BCRL are also concerned. One of the most common morbidity is pain, mostly presenting 1 month after surgery (56.6%). Furthermore, BCRL might decrease shoulder range of motion. Previous study demonstrated that shoulder mobility was usually restricted at 1 month postoperatively and abduction and forward flexion were limited at first. Thus, functional disability may occurred and life of quality may be influenced. To evaluate the ability to perform functional activities, the Disability of Arm, Shoulder, and Hand Questionnaire (DASH) is an useful tool to assess the patients with BCRL.
Currently, although complete decongestive therapy (CDT) has been the standard therapy, there is still various type of noninvasive treatment on BCRL, for example, low-level laser therapy (LLLT). Low-level laser therapy (LLLT), also named photobiomodulation therapy (PBMT), is a conservative therapy through utilizing wave lengths of red or near infrared light between 650 and 1000 nm to stimulate wound healing and reduce inflammation, edema, and pain. Moreover, the Food and Drug Administration (FDA) approved the use of the LLLT for treatment of postmastectomy lymphedema in November 2006. Previous studies have demonstrated the effect of LLLT on BCRL with comparison to physical therapy or placebo. However, there is still limited data about the LLLT with different light area on improvement of severity and symptoms of BCRL. Therefore, 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.
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Exclusion Criteria:
Large-area low-level laser therapy(Venusure) was administered at proximal forearm, upper arm and axillary region of affected side. 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.
Device: Large-area low-level laser therapy(Venusure)
Conventional low-level laser therapy was administrated on antecubital fossa and the axilla of affected side. The wavelength was 808nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks.
Device: Conventional low-level laser therapy
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
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.
Circumference discrepancy of bilateral upper arm
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
Time frame: 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
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
Time frame: 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
Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.
Time frame: Day 120 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
visual analogue scale (VAS)
Record visual analogue scale (VAS) to rate the severity of pain. The total score ranges from 0 to 10. Higher score indicates greater pain intensity.
Time frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Range of motion of involved shoulder
involved upper extremity.
Time frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Skin thickness
Use ultrasound to measure the skin thickness of arm and forearm of involved upper extremity.
Time frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
QuickDASH
QuickDASH(Quick Disabilities of Arm, Shoulder \& Hand) is a questionnaire for patients presenting with self-reported disabilities of the arm, shoulder and hand. The QuickDASH contains 11-items; the score of each item ranges from 1 to 5 and total score ranges from 0 to 100. Higher score indicates greater level of disability and severity.
Time frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Plan to share: No
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