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

July 9, 2025 updated by: Jin A Yoon, MD, Ph.D, Pusan National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seo-Gu
      • Busan, Seo-Gu, Korea, Republic of, 49241
        • Pusan National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Secondary lymphedema following breast cancer surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 904nm LLLT (LTU-904)
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.
Device: Low-Level Laser Therapy (650 nm)
Low-level laser therapy using the Salus Talent device (Remed, USA) at a wavelength of 650 nm, applied to the fibrotic area of the upper limb after CDPT.
Device: Sham Laser Therapy
Placebo laser therapy with no active laser emission, administered after CDPT.
Experimental: 650 nm LLLT (Salus Talent)
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.
Device: Sham Laser Therapy
Placebo laser therapy with no active laser emission, administered after CDPT.
Device: Low-Level Laser Therapy (904 nm)
Low-level laser therapy using the LTU-904 device (RianCorp, Australia) at a wavelength of 904 nm, applied to the fibrotic area of the upper limb after CDPT.
Placebo Comparator: Sham Laser Therapy
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.
Device: Low-Level Laser Therapy (650 nm)
Low-level laser therapy using the Salus Talent device (Remed, USA) at a wavelength of 650 nm, applied to the fibrotic area of the upper limb after CDPT.
Device: Low-Level Laser Therapy (904 nm)
Low-level laser therapy using the LTU-904 device (RianCorp, Australia) at a wavelength of 904 nm, applied to the fibrotic area of the upper limb after CDPT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subcutaneous tissue thickness of the affected upper limb
Time Frame: 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.
Baseline and after 10 sessions (approximately 3 weeks)
Change in dermal backflow (DB) pattern on indocyanine green (ICG) lymphography
Time Frame: 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.
Baseline and after 10 sessions (approximately 3 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Jin A Yoon, MD, Ph.D, Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Actual)

December 26, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

June 20, 2025

First Submitted That Met QC Criteria

July 9, 2025

First Posted (Estimated)

July 18, 2025

Study Record Updates

Last Update Posted (Estimated)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-2310-029-132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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