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Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema

RecruitingNAAges 18 Years - anyFemaleJessa Hospital
NCT04690439 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with breast cancer * Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +/- lymph node dissection * Underwent radiotherapy with or without chemotherapy * Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher) * Age ≥ 18 years * Able to comply to the study protocol * Able to sign written informed consent Exclusion Criteria: * Metastatic disease * Pregnancy * History of surgery or trauma to the arm * History of arm infection in the past 3 months * Use of medications that affect body fluid (e.g., diuretics) in the last 3 months * Severe psychological disorder or dementia * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
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What it tests

  • Photobiomodulation therapy (PBMT)
  • Manual Lymphatic drainage
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Where

2 sites
Hasselt University
Hasselt, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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