LLLT for BCRL: a Randomized, Placebo-controlled Study

NCT05725265 | Recruiting

• 1 other identifier: 202210064DIPD
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema. The change of severity of BCRL will be measured by the difference of circumference and skin thickness, detected by ultrasound. The influence on clinical symptoms, such as pain, shoulder mobility and hand function, are also investigated in the study.

Conditions

Breast Cancer Lymphedema

Keywords

Breast Cancer Lymphedema; Lymphedema; Breast cancer; Low level laser therapy

Outcome Measures

Primary Outcomes (3)

• Circumference discrepancy of bilateral upper arm

  Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.

  Day 30 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section

• Circumference discrepancy of bilateral upper arm

  Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.

  Day 60 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section

• Circumference discrepancy of bilateral upper arm

  Record the circumference of arm and forearm of involved and uninvolved upper extremity at 4 cm segment from cubital fossa and calculate the circumference discrepancy.

  Day 120 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section

Secondary Outcomes (4)

• visual analogue scale (VAS)

  Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section

• Range of motion of involved shoulder

  Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section

• Skin thickness

  Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section

• QuickDASH

  Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section

Study Arms (2)

Large-area low-level laser therapy

EXPERIMENTAL

Large-area low-level laser therapy(Venusure) was administered at proximal forearm, upper arm and axillary region of affected side. The wavelength was 980±15nm, average dose was 10-40nm/cm2 and maximal output was 1000mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks.

Device: Large-area low-level laser therapy(Venusure)

Conventional low-level laser therapy

PLACEBO COMPARATOR

Conventional low-level laser therapy was administrated on antecubital fossa and the axilla of affected side. The wavelength was 808nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks.

Device: Conventional low-level laser therapy

Interventions

Large-area low-level laser therapy(Venusure) DEVICE

The wavelength was 980±15nm, average dose was 10-40nm/cm2 and maximal output was 1000mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions

Large-area low-level laser therapy

Conventional low-level laser therapy DEVICE

The wavelength was 808 nm and maximal output was 60 mW. Total treatment duration was 30 min and frequency was 3 sessions/week for 4 weeks; for a total of 12 sessions.

Conventional low-level laser therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects, 20 years age or older, suffered from unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection (sentinel biopsy or axillary dissection)
• Stage I or II unilateral secondary upper extremity lymphedema(as defined by the International Society of Lymphology)
• Girth≥ 2 cm circumferential difference compared with the uninvolved upper extremity at any 4 cm segment
• Able to commit to a long-term follow-up schedule

You may not qualify if:

• Metastatic cancer(stage IV)
• Pregnancy
• Presence of other extremity lymphedema (primary or secondary)
• History of deep vein thrombosis
• Pacemaker
• Artificial joints, implant or tattoo(area≥4 cm2) at the involved upper extremity
• Previous treatment with low-level laser therapy (within 3 months)
• Body mass index (BMI) \> 35 (morbid obesity)
• High bleeding tendency(hemophilia)
• Receiving long-term steroid treatment (oral or systemic)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (11)

• DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.

  PMID: 23540561 BACKGROUND

• Grada AA, Phillips TJ. Lymphedema: Pathophysiology and clinical manifestations. J Am Acad Dermatol. 2017 Dec;77(6):1009-1020. doi: 10.1016/j.jaad.2017.03.022.

  PMID: 29132848 BACKGROUND

• Eyigor S, Cinar E, Caramat I, Unlu BK. Factors influencing response to lymphedema treatment in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Sep;23(9):2705-10. doi: 10.1007/s00520-015-2633-9. Epub 2015 Feb 8.

  PMID: 25663541 BACKGROUND

• Mellor RH, Bush NL, Stanton AW, Bamber JC, Levick JR, Mortimer PS. Dual-frequency ultrasound examination of skin and subcutis thickness in breast cancer-related lymphedema. Breast J. 2004 Nov-Dec;10(6):496-503. doi: 10.1111/j.1075-122X.2004.21458.x.

  PMID: 15569205 BACKGROUND

• Swenson KK, Nissen MJ, Ceronsky C, Swenson L, Lee MW, Tuttle TM. Comparison of side effects between sentinel lymph node and axillary lymph node dissection for breast cancer. Ann Surg Oncol. 2002 Oct;9(8):745-53. doi: 10.1007/BF02574496.

  PMID: 12374657 BACKGROUND

• Verbelen H, Gebruers N, Eeckhout FM, Verlinden K, Tjalma W. Shoulder and arm morbidity in sentinel node-negative breast cancer patients: a systematic review. Breast Cancer Res Treat. 2014 Feb;144(1):21-31. doi: 10.1007/s10549-014-2846-5. Epub 2014 Feb 5.

  PMID: 24496928 BACKGROUND

• Lee D, Hwang JH, Chu I, Chang HJ, Shim YH, Kim JH. Analysis of factors related to arm weakness in patients with breast cancer-related lymphedema. Support Care Cancer. 2015 Aug;23(8):2297-304. doi: 10.1007/s00520-014-2584-6. Epub 2015 Jan 10.

  PMID: 25576430 BACKGROUND

• Smile TD, Tendulkar R, Schwarz G, Arthur D, Grobmyer S, Valente S, Vicini F, Shah C. A Review of Treatment for Breast Cancer-Related Lymphedema: Paradigms for Clinical Practice. Am J Clin Oncol. 2018 Feb;41(2):178-190. doi: 10.1097/COC.0000000000000355.

  PMID: 28009597 BACKGROUND

• Robijns J, Censabella S, Bulens P, Maes A, Mebis J. The use of low-level light therapy in supportive care for patients with breast cancer: review of the literature. Lasers Med Sci. 2017 Jan;32(1):229-242. doi: 10.1007/s10103-016-2056-y. Epub 2016 Aug 19.

  PMID: 27539464 BACKGROUND

• Wang Y, Ge Y, Xing W, Liu J, Wu J, Lin H, Lu Y. The effectiveness and safety of low-level laser therapy on breast cancer-related lymphedema: An overview and update of systematic reviews. Lasers Med Sci. 2022 Apr;37(3):1389-1413. doi: 10.1007/s10103-021-03446-3. Epub 2021 Nov 15.

  PMID: 34779937 BACKGROUND

• Levenhagen K, Davies C, Perdomo M, Ryans K, Gilchrist L. Diagnosis of Upper Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of the American Physical Therapy Association. Phys Ther. 2017 Jul 1;97(7):729-745. doi: 10.1093/ptj/pzx050.

  PMID: 28838217 BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chueh-Hung Wu, PHD

  Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan

  STUDY CHAIR

Central Study Contacts

Ying-Chun Chen, MD

CONTACT

23123456; yasandy2000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: February 13, 2023
• Study Start: October 24, 2023
• Primary Completion: July 31, 2025
• Study Completion: October 31, 2025
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)