Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04690439

Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

Led by Jessa Hospital · Updated on 2023-02-28

104

Participants Needed

2

Research Sites

362 weeks

Total Duration

On this page

Sponsors

J

Jessa Hospital

Lead Sponsor

H

Hasselt University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.

CONDITIONS

Official Title

Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with breast cancer
  • Underwent ipsilateral lumpectomy or mastectomy plus sentinel lymph node biopsy with or without lymph node dissection
  • Received radiotherapy with or without chemotherapy
  • Diagnosed with breast cancer-related lymphedema at stage I or higher
  • Age 18 years or older
  • Able to follow the study protocol
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Metastatic disease
  • Pregnancy
  • History of surgery or trauma to the arm
  • History of arm infection within the past 3 months
  • Use of medications affecting body fluids (like diuretics) in the last 3 months
  • Severe psychological disorder or dementia
  • Any unstable condition that may affect patient safety or study compliance as determined by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Hasselt University

Hasselt, Limburg, Belgium, 3500

Actively Recruiting

2

Jessa Ziekenhuis

Hasselt, Limburg, Belgium, 3500

Actively Recruiting

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Research Team

J

Jolien Robijns, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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