Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema
Recruiting · NCT04690439 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
2 locations listed.
- Hasselt University - Hasselt, Limburg, Belgium
- Jessa Ziekenhuis - Hasselt, Limburg, Belgium