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

Pusan National University

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Low-Level Laser Therapy (904 nm); Device: Sham Laser Therapy; Device: Low-Level Laser Therapy (650 nm)

Study type: Interventional

Funder types: Other

Identifiers

NCT07072780

D-2310-029-132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Secondary lymphedema following breast cancer surgery

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 3 patient groups, including a placebo group

904nm LLLT (LTU-904)

Experimental group

Description:

Participants will receive low-level laser therapy using the LTU-904 device at a wavelength of 904 nm after complex decongestive physiotherapy (CDPT), which includes manual lymphatic drainage, remedial exercises, and intermittent pneumatic compression.

Treatment:

Device: Low-Level Laser Therapy (650 nm)

Device: Sham Laser Therapy

650 nm LLLT (Salus Talent)

Experimental group

Description:

Participants will receive low-level laser therapy using the Salus Talent device at a wavelength of 650 nm after complex decongestive physiotherapy (CDPT), which includes manual lymphatic drainage, remedial exercises, and intermittent pneumatic compression.

Treatment:

Device: Sham Laser Therapy

Device: Low-Level Laser Therapy (904 nm)

Sham Laser Therapy

Placebo Comparator group

Description:

Participants will receive sham laser therapy with no active laser emission after complex decongestive physiotherapy (CDPT), which includes manual lymphatic drainage, remedial exercises, and intermittent pneumatic compression.

Treatment:

Device: Low-Level Laser Therapy (650 nm)

Device: Low-Level Laser Therapy (904 nm)