LLLT for BCRL: a Randomized, Placebo-controlled Study

October 16, 2024 updated by: National Taiwan University Hospital

Large-area Low-level Laser Therapy for Breast Cancer-related Lymphedema: a Randomized, Placebo-controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Large-area low-level laser therapy
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)
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
Placebo Comparator: Conventional low-level laser therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circumference discrepancy of bilateral upper arm
Time Frame: Day 30 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
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
Time Frame: Day 60 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
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
Time Frame: Day 120 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale (VAS)
Time Frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
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.
Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Range of motion of involved shoulder
Time Frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
involved upper extremity.
Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Skin thickness
Time Frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
Use ultrasound to measure the skin thickness of arm and forearm of involved upper extremity.
Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
QuickDASH
Time Frame: Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
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.
Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Chueh-Hung Wu, PHD, Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, Taipei, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

January 8, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202210064DIPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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