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LLLT for BCRL: a Randomized, Placebo-controlled Study

Primary Purpose

Breast Cancer Lymphedema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Large-area low-level laser therapy(Venusure)
Conventional low-level laser therapy
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Lymphedema focused on measuring Breast Cancer Lymphedema, Lymphedema, Breast cancer, Low level laser therapy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Large-area low-level laser therapy

    Conventional low-level laser therapy

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    visual analogue scale (VAS)
    Record visual analogue scale (VAS) to rate the severity of pain. The total score ranges from 0 to 10. Higher score indicates greater pain intensity.
    Range of motion of involved shoulder
    involved upper extremity.
    Skin thickness
    Use ultrasound to measure the skin thickness of arm and forearm of involved upper extremity.
    QuickDASH
    QuickDASH(Quick Disabilities of Arm, Shoulder & Hand) is a questionnaire for patients presenting with self-reported disabilities of the arm, shoulder and hand. The QuickDASH contains 11-items; the score of each item ranges from 1 to 5 and total score ranges from 0 to 100. Higher score indicates greater level of disability and severity.

    Full Information

    First Posted
    January 8, 2023
    Last Updated
    February 1, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05725265
    Brief Title
    LLLT for BCRL: a Randomized, Placebo-controlled Study
    Official Title
    Large-area Low-level Laser Therapy for Breast Cancer-related Lymphedema: a Randomized, Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Breast cancer-related lymphedema (BCRL) is common complication after cancer treatment. The incidence of BCRL around is 16.6% (95% CI 13·6-20·2) after the diagnosis and higher among the group receiving the sentinel biopsy or axillary lymph dissection. The lymphedema arises from the accumulation of protein-rich lymph fluid in the interstitial spaces then results in chronic inflammation with symptoms of fibrosis, pain, limited range of motion or paresthesia. The BRCL is chronic and progressive condition, and the severity also changes over time. The definition and cut points of BCRL using inter-limb volume or arm circumference varied across the studies by different measure method. Currently, the International Society of Lymphology suggests calculating arm volume from circumferences through the truncated cone formula to qualify the severity. On the other hand, previous research found the skin and subcutis were thickened in the ipsilateral arm of patients with BCRL. Thus, the measurement of skin thickness using ultrasound may also practical to detect the progression of lymphedema. Except for physical change of upper limb, the symptoms of BCRL are also concerned. One of the most common morbidity is pain, mostly presenting 1 month after surgery (56.6%). Furthermore, BCRL might decrease shoulder range of motion. Previous study demonstrated that shoulder mobility was usually restricted at 1 month postoperatively and abduction and forward flexion were limited at first. Thus, functional disability may occurred and life of quality may be influenced. To evaluate the ability to perform functional activities, the Disability of Arm, Shoulder, and Hand Questionnaire (DASH) is an useful tool to assess the patients with BCRL. Currently, although complete decongestive therapy (CDT) has been the standard therapy, there is still various type of noninvasive treatment on BCRL, for example, low-level laser therapy (LLLT). Low-level laser therapy (LLLT), also named photobiomodulation therapy (PBMT), is a conservative therapy through utilizing wave lengths of red or near infrared light between 650 and 1000 nm to stimulate wound healing and reduce inflammation, edema, and pain. Moreover, the Food and Drug Administration (FDA) approved the use of the LLLT for treatment of postmastectomy lymphedema in November 2006. Previous studies have demonstrated the effect of LLLT on BCRL with comparison to physical therapy or placebo. However, there is still limited data about the LLLT with different light area on improvement of severity and symptoms of BCRL. Therefore, 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer Lymphedema
    Keywords
    Breast Cancer Lymphedema, Lymphedema, Breast cancer, Low level laser therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Large-area low-level laser therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conventional low-level laser therapy
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Large-area low-level laser therapy(Venusure)
    Intervention Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    Conventional low-level laser therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Circumference discrepancy of bilateral upper arm
    Description
    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.
    Time Frame
    Day 30 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
    Title
    Circumference discrepancy of bilateral upper arm
    Description
    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.
    Time Frame
    Day 60 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
    Title
    Circumference discrepancy of bilateral upper arm
    Description
    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.
    Time Frame
    Day 90 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
    Title
    Circumference discrepancy of bilateral upper arm
    Description
    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.
    Time Frame
    Day 120 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
    Secondary Outcome Measure Information:
    Title
    visual analogue scale (VAS)
    Description
    Record visual analogue scale (VAS) to rate the severity of pain. The total score ranges from 0 to 10. Higher score indicates greater pain intensity.
    Time Frame
    Day 30, Day 60, Day 90, Day 120 (comparing with the data in baseline) of each section
    Title
    Range of motion of involved shoulder
    Description
    involved upper extremity.
    Time Frame
    Day 30, Day 60, Day 90, Day 120 (comparing with the data in baseline) of each section
    Title
    Skin thickness
    Description
    Use ultrasound to measure the skin thickness of arm and forearm of involved upper extremity.
    Time Frame
    Day 30, Day 60, Day 90, Day 120 (comparing with the data in baseline) of each section
    Title
    QuickDASH
    Description
    QuickDASH(Quick Disabilities of Arm, Shoulder & Hand) is a questionnaire for patients presenting with self-reported disabilities of the arm, shoulder and hand. The QuickDASH contains 11-items; the score of each item ranges from 1 to 5 and total score ranges from 0 to 100. Higher score indicates greater level of disability and severity.
    Time Frame
    Day 30, Day 60, Day 90, Day 120 (comparing with the data in baseline) of each section

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    I-Chun Liu, MD
    Phone
    23123456
    Ext
    53350
    Email
    jacy50521@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chueh-Hung Wu, PHD
    Organizational Affiliation
    Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23540561
    Citation
    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.
    Results Reference
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    PubMed Identifier
    29132848
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25663541
    Citation
    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.
    Results Reference
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    PubMed Identifier
    15569205
    Citation
    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.
    Results Reference
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    PubMed Identifier
    12374657
    Citation
    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.
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    PubMed Identifier
    24496928
    Citation
    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.
    Results Reference
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    PubMed Identifier
    25576430
    Citation
    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.
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    PubMed Identifier
    28009597
    Citation
    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.
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    PubMed Identifier
    27539464
    Citation
    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.
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    PubMed Identifier
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    Citation
    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.
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    LLLT for BCRL: a Randomized, Placebo-controlled Study

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