LLLT for BCRL: a Randomized, Placebo-controlled Study

Trial Title: LLLT for BCRL: a Randomized, Placebo-controlled Study

NCT ID: NCT05725265

Condition: Breast Cancer Lymphedema

Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema

Conditions: Keywords:
Breast Cancer Lymphedema
Lymphedema
Breast cancer
Low level laser therapy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Large-area low-level laser therapy(Venusure)
Description: 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
Arm group label: Large-area low-level laser therapy

Intervention type: Device
Intervention name: Conventional low-level laser therapy
Description: 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.
Arm group label: Conventional low-level laser therapy

Summary: 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.

Detailed description: 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.

Criteria for 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)

Gender: Female

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Taiwan University Hospital

Address:
City: Taipei
Country: Taiwan

Status: Recruiting

Contact:
Last name: Ying-Chun Chen, MD

Phone: 23123456

Phone ext: 55177
Email: yasandy2000@gmail.com

Start date: October 24, 2023

Completion date: October 31, 2025

Lead sponsor:
Agency: National Taiwan University Hospital
Agency class: Other

Source: National Taiwan University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05725265