Health TrialsbyHealthPanel

LLLT for BCRL: a Randomized, Placebo-controlled Study

ConditionBreast Cancer Lymphedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Metastatic cancer(stage IV)

Pregnancy

Presence of other extremity lymphedema (primary or secondary)

History of deep vein thrombosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Large-area low-level laser therapyExperimental treatment 1 intervention
Group B: Conventional low-level laser therapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 30 (change of circumference discrepancy of bilateral upper limbs, comparing with the data in baseline) of each section
2

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.

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

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

Secondary outcomes

1

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.

Time frame
Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
2

Range of motion of involved shoulder

involved upper extremity.

Time frame
Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
3

Skin thickness

Use ultrasound to measure the skin thickness of arm and forearm of involved upper extremity.

Time frame
Day 30, Day 60, Day 120 (comparing with the data in baseline) of each section
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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