Clinical trial · Interventional
Effectiveness of a Novel Low-level Laser Therapy Protocol in Managing Breast Cancer-Related Lymphedema
NCT07072780CI-TRIAL-00092303completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-Level Laser Therapy (650 nm) | Device | — | UNRESOLVED |
| Low-Level Laser Therapy (904 nm) | Device | — | UNRESOLVED |
| Sham Laser Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 904nm LLLT (LTU-904)
- 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.
- interventionNames
- Device: Low-Level Laser Therapy (650 nm)
- Device: Sham Laser Therapy
- type
- EXPERIMENTAL
- label
- 650 nm LLLT (Salus Talent)
- 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.
- interventionNames
- Device: Low-Level Laser Therapy (904 nm)
- Device: Sham Laser Therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Secondary lymphedema following breast cancer surgery Exclusion Criteria: * Primary lymphedema * History of trauma, metastasis, or infection in both arms
References
Publications (28)
- BACKGROUNDAhmed Omar MT, Abd-El-Gayed Ebid A, El Morsy AM. Treatment of post-mastectomy lymphedema with laser therapy: double blind placebo control randomized study. J Surg Res. 2011 Jan;165(1):82-90. doi: 10.1016/j.jss.2010.03.050. Epub 2010 Apr 18. PMID 20538293
- BACKGROUNDJang DH, Song DH, Chang EJ, Jeon JY. Anti-inflammatory and lymphangiogenetic effects of low-level laser therapy on lymphedema in an experimental mouse tail model. Lasers Med Sci. 2016 Feb;31(2):289-96. doi: 10.1007/s10103-015-1854-y. Epub 2015 Dec 29. PMID 26714983
- BACKGROUNDDirican A, Andacoglu O, Johnson R, McGuire K, Mager L, Soran A. The short-term effects of low-level laser therapy in the management of breast-cancer-related lymphedema. Support Care Cancer. 2011 May;19(5):685-90. doi: 10.1007/s00520-010-0888-8. Epub 2010 May 6. PMID 20445997
- BACKGROUNDMayrovitz HN, Davey S. Changes in tissue water and indentation resistance of lymphedematous limbs accompanying low level laser therapy (LLLT) of fibrotic skin. Lymphology. 2011 Dec;44(4):168-77. PMID 22458118
- BACKGROUNDBerger AM, Mooney K, Alvarez-Perez A, Breitbart WS, Carpenter KM, Cella D, Cleeland C, Dotan E, Eisenberger MA, Escalante CP, Jacobsen PB, Jankowski C, LeBlanc T, Ligibel JA, Loggers ET, Mandrell B, Murphy BA, Palesh O, Pirl WF, Plaxe SC, Riba MB, Rugo HS, Salvador C, Wagner LI, Wagner-Johnston ND, Zachariah FJ, Bergman MA, Smith C; National comprehensive cancer network. Cancer-Related Fatigue, Version 2.2015. J Natl Compr Canc Netw. 2015 Aug;13(8):1012-39. doi: 10.6004/jnccn.2015.0122. PMID 26285247
- BACKGROUNDBuso G, Depairon M, Tomson D, Raffoul W, Vettor R, Mazzolai L. Lipedema: A Call to Action! Obesity (Silver Spring). 2019 Oct;27(10):1567-1576. doi: 10.1002/oby.22597. PMID 31544340
- BACKGROUNDGustavsson S, Kelly KA, Hench VS, Melton LJ 3rd. Giant gastric and duodenal ulcers: a population-based study with a comparison to nongiant ulcers. World J Surg. 1987 Jun;11(3):333-8. doi: 10.1007/BF01658111. No abstract available.