NCT04690439 Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema
| NCT ID | NCT04690439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jessa Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2021-02-22 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 104 participants in total. It began in 2021-02-22 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Jeroen Mebis, MD, PhD
PRINCIPAL INVESTIGATOR
Jessa Hospital
Frequently Asked Questions
Who can join the NCT04690439 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04690439 currently recruiting?
Yes, NCT04690439 is actively recruiting participants. Contact the research team at jolien.robijns@jessazh.be for enrollment information.
Where is the NCT04690439 trial being conducted?
This trial is being conducted at Hasselt, Belgium, Hasselt, Belgium.
Who is sponsoring the NCT04690439 clinical trial?
NCT04690439 is sponsored by Jessa Hospital. The principal investigator is Jeroen Mebis, MD, PhD at Jessa Hospital. The trial plans to enroll 104 participants.
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