Effectiveness of a Novel Low-level Laser Therapy Protocol in Managing Breast Cancer-Related Lymphedema
NCT07072780 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2025-07-18
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.
Conditions
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Pusan National University Hospital
lead OTHER
Principal Investigators
-
Jin A Yoon, MD, Ph.D · Pusan National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-23
- Primary Completion
- 2024-12-26
- Completion
- 2024-12-31
Countries
- South Korea
Study Locations
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