Breast CancerNCT07072780
Effectiveness of a Novel Low-level Laser Therapy Protocol in Managing Breast Cancer-Related Lymphedema
A study testing Low-Level Laser Therapy (904 nm) and Low-Level Laser Therapy (650 nm) in people with Breast Cancer, run by Pusan National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Low-Level Laser Therapy (904 nm) and Low-Level Laser Therapy (650 nm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Nov 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Secondary lymphedema following breast cancer surgery
Who cannot join
- Primary lymphedema
- History of trauma, metastasis, or infection in both arms
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Low-Level Laser Therapy (904 nm), Low-Level Laser Therapy (650 nm), Sham Laser Therapy
- Keywords
- Low-level laser therapy, LLLT, Photobiomodulation, Randomized controlled trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser Therapy (904 nm)Device
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.
Low-Level Laser Therapy (650 nm)Device
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.
Sham Laser TherapyDevice
Placebo laser therapy with no active laser emission, administered after CDPT.
| Study group | Role | What they receive |
|---|---|---|
| 904nm LLLT (LTU-904) | Experimental | 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. Receives: Device: Low-Level Laser Therapy (650 nm); Device: Sham Laser Therapy |
| 650 nm LLLT (Salus Talent) | Experimental | 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. Receives: Device: Low-Level Laser Therapy (904 nm); Device: Sham Laser Therapy |
| Sham Laser Therapy | Placebo comparator | 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. Receives: Device: Low-Level Laser Therapy (904 nm); Device: Low-Level Laser Therapy (650 nm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subcutaneous tissue thickness of the affected upper limb
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.
Measured: Baseline and after 10 sessions (approximately 3 weeks)
Change in dermal backflow (DB) pattern on indocyanine green (ICG) lymphography
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.
Measured: Baseline and after 10 sessions (approximately 3 weeks)
Secondary outcomes (2)
Change in extracellular fluid (ECF) ratio
ECF ratio will be assessed using multi-frequency bioimpedance analysis (MFBIA).
Measured: Baseline and after 10 sessions (approximately 3 weeks)
Change in upper limb volume
Arm volume will be measured using standardized circumferential measurements and calculated using the truncated cone formula.
Measured: Baseline and after 10 sessions (approximately 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start23 Nov 2023
- Primary completion26 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin A Yoon, MD, Ph.D, Pusan National University Hospital
- Investigators
- Jin A Yoon, MD, Ph.D, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072780
- Sponsor's protocol ID
- D-2310-029-132
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed 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.
PubMed 20538293Jang 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.
PubMed 26714983Dirican 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.
PubMed 20445997Mayrovitz 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.
PubMed 22458118Berger 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.
PubMed 26285247Buso 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.
PubMed 31544340Gustavsson 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.
PubMed 3604241Assis L, Moretti AI, Abrahao TB, de Souza HP, Hamblin MR, Parizotto NA. Low-level laser therapy (808 nm) contributes to muscle regeneration and prevents fibrosis in rat tibialis anterior muscle after cryolesion. Lasers Med Sci. 2013 May;28(3):947-55. doi: 10.1007/s10103-012-1183-3. Epub 2012 Aug 17.
PubMed 22898787Smoot B, Chiavola-Larson L, Lee J, Manibusan H, Allen DD. Effect of low-level laser therapy on pain and swelling in women with breast cancer-related lymphedema: a systematic review and meta-analysis. J Cancer Surviv. 2015 Jun;9(2):287-304. doi: 10.1007/s11764-014-0411-1. Epub 2014 Nov 29.
PubMed 25432632De Vrieze T, Vos L, Gebruers N, Tjalma WAA, Thomis S, Neven P, Nevelsteen I, De Groef A, Vandermeeren L, Belgrado JP, Devoogdt N. Protocol of a randomised controlled trial regarding the effectiveness of fluoroscopy-guided manual lymph drainage for the treatment of breast cancer-related lymphoedema (EFforT-BCRL trial). Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:177-188. doi: 10.1016/j.ejogrb.2017.12.023. Epub 2017 Dec 16.
PubMed 29277358Kilmartin L, Denham T, Fu MR, Yu G, Kuo TT, Axelrod D, Guth AA. Complementary low-level laser therapy for breast cancer-related lymphedema: a pilot, double-blind, randomized, placebo-controlled study. Lasers Med Sci. 2020 Feb;35(1):95-105. doi: 10.1007/s10103-019-02798-1. Epub 2019 May 11.
PubMed 31079232Szuba A, Shin WS, Strauss HW, Rockson S. The third circulation: radionuclide lymphoscintigraphy in the evaluation of lymphedema. J Nucl Med. 2003 Jan;44(1):43-57.
PubMed 12515876Unno N, Nishiyama M, Suzuki M, Tanaka H, Yamamoto N, Sagara D, Mano Y, Konno H. A novel method of measuring human lymphatic pumping using indocyanine green fluorescence lymphography. J Vasc Surg. 2010 Oct;52(4):946-52. doi: 10.1016/j.jvs.2010.04.067.
PubMed 20619581Yamamoto T, Yamamoto N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. Indocyanine green-enhanced lymphography for upper extremity lymphedema: a novel severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 Oct;128(4):941-947. doi: 10.1097/PRS.0b013e3182268cd9.
PubMed 21681123Narushima M, Yamamoto T, Ogata F, Yoshimatsu H, Mihara M, Koshima I. Indocyanine Green Lymphography Findings in Limb Lymphedema. J Reconstr Microsurg. 2016 Jan;32(1):72-9. doi: 10.1055/s-0035-1564608. Epub 2015 Sep 30.
PubMed 26422172
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Novel Low-level Laser Therapy Protocol in Managing Breast Cancer-Related Lymphedema
- ClinicalTrials.gov ID
- NCT07072780
- Acronym / sponsor ID
- D-2310-029-132
- Conditions
- Breast Cancer
- Keywords
- Low-level laser therapy, LLLT, Photobiomodulation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 904nm LLLT (LTU-904) | Experimental | Device: Low-Level Laser Therapy (650 nm), Device: Sham Laser TherapyParticipants 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. |
| 650 nm LLLT (Salus Talent) | Experimental | Device: Low-Level Laser Therapy (904 nm), Device: Sham Laser TherapyParticipants 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. |
| Sham Laser Therapy | Placebo comparator | Device: Low-Level Laser Therapy (904 nm), Device: Low-Level Laser Therapy (650 nm)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Secondary lymphedema following breast cancer surgery
Key exclusion criteria (2 listed)
- Primary lymphedema
- History of trauma, metastasis, or infection in both arms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 650 nm LLLT (Salus Talent), Sham Laser Therapy |
| 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 | 904nm LLLT (LTU-904), Sham Laser Therapy |
| Sham Laser TherapyPlacebo laser therapy with no active laser emission, administered after CDPT. | Device | 650 nm LLLT (Salus Talent), 904nm LLLT (LTU-904) |
Primary outcome
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.
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.
2 secondary outcomes
Change in extracellular fluid (ECF) ratio
Time frame: Baseline and after 10 sessions (approximately 3 weeks)
Change in upper limb volume
Time frame: Baseline and after 10 sessions (approximately 3 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 20538293Ahmed 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.
- Background: PubMed 26714983Jang 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.
- Background: PubMed 20445997Dirican 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.
- Background: PubMed 22458118Mayrovitz 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.
- Background: PubMed 26285247Berger 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.
- Background: PubMed 31544340Buso 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.
- Background: PubMed 3604241Gustavsson 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.
- Background: PubMed 22898787Assis L, Moretti AI, Abrahao TB, de Souza HP, Hamblin MR, Parizotto NA. Low-level laser therapy (808 nm) contributes to muscle regeneration and prevents fibrosis in rat tibialis anterior muscle after cryolesion. Lasers Med Sci. 2013 May;28(3):947-55. doi: 10.1007/s10103-012-1183-3. Epub 2012 Aug 17.
- Background: PubMed 25432632Smoot B, Chiavola-Larson L, Lee J, Manibusan H, Allen DD. Effect of low-level laser therapy on pain and swelling in women with breast cancer-related lymphedema: a systematic review and meta-analysis. J Cancer Surviv. 2015 Jun;9(2):287-304. doi: 10.1007/s11764-014-0411-1. Epub 2014 Nov 29.
- Background: PubMed 29277358De Vrieze T, Vos L, Gebruers N, Tjalma WAA, Thomis S, Neven P, Nevelsteen I, De Groef A, Vandermeeren L, Belgrado JP, Devoogdt N. Protocol of a randomised controlled trial regarding the effectiveness of fluoroscopy-guided manual lymph drainage for the treatment of breast cancer-related lymphoedema (EFforT-BCRL trial). Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:177-188. doi: 10.1016/j.ejogrb.2017.12.023. Epub 2017 Dec 16.
- Background: PubMed 31079232Kilmartin L, Denham T, Fu MR, Yu G, Kuo TT, Axelrod D, Guth AA. Complementary low-level laser therapy for breast cancer-related lymphedema: a pilot, double-blind, randomized, placebo-controlled study. Lasers Med Sci. 2020 Feb;35(1):95-105. doi: 10.1007/s10103-019-02798-1. Epub 2019 May 11.
- Background: PubMed 12515876Szuba A, Shin WS, Strauss HW, Rockson S. The third circulation: radionuclide lymphoscintigraphy in the evaluation of lymphedema. J Nucl Med. 2003 Jan;44(1):43-57.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin A Yoon, MD, Ph.D principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser Therapy (904 nm) and Low-Level Laser Therapy (650 nm) in people with Breast Cancer, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subcutaneous tissue thickness of the affected upper limb (time frame: Baseline and after 10 sessions (approximately 3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07072780, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.