Effectiveness of a Novel Low-level Laser Therapy Protocol in Managing Breast Cancer-Related Lymphedema

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT07072780
• Lead Sponsor: Pusan National University Hospital

Brief Summary

This study is a prospective, single-blinded, randomized controlled trial designed to evaluate the effectiveness of low-level laser therapy (LLLT) using two different wavelengths (904 nm and 650 nm) in patients with secondary lymphedema following breast cancer surgery. Participants will be randomly assigned to one of three groups: 904 nm LLLT, 650 nm LLLT, or sham treatment. The primary objective is to assess changes in arm volume and secondary lymphedema-related outcomes following a structured intervention program.

Detailed Description

This single-blinded, parallel-group, randomized controlled trial will be conducted at a tertiary hospital. Eligible participants are women diagnosed with secondary lymphedema after breast cancer surgery. Patients with primary lymphedema, history of upper limb trauma, bilateral arm infection, or metastasis will be excluded. Participants will be randomized into three groups: Group A (904 nm LLLT), Group B (650 nm LLLT), and a sham group.

Each participant will receive ten treatment sessions. Every session will consist of 60 minutes of conventional complex decongestive physiotherapy (CDPT), including manual lymphatic drainage, remedial exercises, and intermittent pneumatic compression, followed by 20 minutes of laser therapy. All participants will receive fluoroscopy-guided manual lymphatic drainage during each session.

The 904 nm wavelength laser (LTU-904, RianCorp) and the 650 nm laser (Salus Talent, Remed) will deliver the same energy dose (22.5 J/cm²) during treatment. The sham group will receive placebo treatment with no active laser emission. Laser therapy will be applied to the most fibrotic area of the affected upper limb in a circular area approximately 7 cm in diameter. The irradiation will be performed point-by-point with 1 cm intervals. Five-minute rest intervals will be given between treatments.

Randomization will be conducted using stratified block randomization (block size of 4), and allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. Participants will be blinded to the wavelength used. Outcome assessors will also be blinded to group allocation.

The primary outcome is change in upper limb volume. Secondary outcomes include changes in extracellular fluid ratio, tissue dielectric constant, circumferential measurements. Pre- and post-intervention assessments will be conducted.

Study Timeline

• Study Start: 2023-11-23
• Primary Completion: 2024-12-26
• Study Completion: 2024-12-31
• Study First Submitted: 2025-06-20
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Secondary lymphedema following breast cancer surgery

Exclusion Criteria

• Primary lymphedema
• History of trauma, metastasis, or infection in both arms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in subcutaneous tissue thickness of the affected upper limb	Baseline and after 10 sessions (approximately 3 weeks)	Subcutaneous tissue thickness will be measured using B-mode ultrasonography (7.5 MHz linear-array transducer, Siemens Medical Solutions). Measurements will be taken at five predefined anatomical sites of the affected upper limb: (1) midpoint of the wrist crease, (2) medial epicondyle, (3) lateral epicondyle, (4) 10 cm proximal and distal to the elbow joint along predefined lines on both medial and lateral sides, and (5) the web space between the first and second fingers. Thickness values will be used to assess local soft tissue changes in response to treatment.
Change in dermal backflow (DB) pattern on indocyanine green (ICG) lymphography	Baseline and after 10 sessions (approximately 3 weeks)	Indocyanine green (Diagnogreen, 2.5 mg/mL) will be injected intradermally into the first and third web spaces of the affected hand (0.1 mL per site). To minimize discomfort, lidocaine HCl 2% with epinephrine (1:100,000) will be administered prior to injection. Lymphatic flow will be visualized using near-infrared fluorescence imaging. Dermal backflow patterns will be classified from Type I to Type V according to established staging criteria, reflecting the severity and distribution of lymphatic stasis. The DB stage will be used as an indicator of lymphatic dysfunction and treatment response.

Secondary Outcome Measures

Name	Time	Method
Change in extracellular fluid (ECF) ratio	Baseline and after 10 sessions (approximately 3 weeks)	ECF ratio will be assessed using multi-frequency bioimpedance analysis (MFBIA).
Change in upper limb volume	Baseline and after 10 sessions (approximately 3 weeks)	Arm volume will be measured using standardized circumferential measurements and calculated using the truncated cone formula.

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Seo-Gu, Korea, Republic of