Actively Recruiting

Phase Not Applicable
Age: 20Years +
FEMALE
NCT05725265

LLLT for BCRL: a Randomized, Placebo-controlled Study

Led by National Taiwan University Hospital · Updated on 2024-10-18

54

Participants Needed

1

Research Sites

105 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

LLLT for BCRL: a Randomized, Placebo-controlled Study

Who Can Participate

Age: 20Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, 20 years or older
  • Unilateral breast cancer with ipsilateral lumpectomy or mastectomy and lymph node dissection
  • Stage I or II unilateral secondary upper extremity lymphedema
  • At least 2 cm circumference difference compared to the unaffected arm at any 4 cm segment
  • Able to commit to long-term follow-up
Not Eligible

You will not qualify if you...

  • Metastatic cancer (stage IV)
  • Pregnancy
  • Other extremity lymphedema (primary or secondary)
  • History of deep vein thrombosis
  • Pacemaker
  • Artificial joints, implant, or tattoo larger than 4 cm2 on the affected arm
  • Previous low-level laser therapy within 3 months
  • Body mass index over 35 (morbid obesity)
  • High bleeding tendency (hemophilia)
  • Receiving long-term oral or systemic steroid treatment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

Y

Ying-Chun Chen, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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