Using light therapy to manage lymphedema in breast cancer patients
Official title: Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial
Run by Jessa Hospital · NCT04690439 · Data updated 2026-11-12
This study is testing if a combination of light therapy and massage can help breast cancer patients with lymphedema reduce swelling, relieve pain, and improve their quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 104 (estimated) |
| Sponsor | Jessa Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Hasselt, Limburg and 1 other locations) |
| Status | Recruiting |
| Started | February 22, 2021 |
| Main results expected | February 2028 |
| Study ends | February 2028 |
| Registry record updated | February 28, 2023 |
| Trial ID | NCT04690439 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been diagnosed with breast cancer and are experiencing lymphedema following surgery.
✕Probably not a fit
Patients with metastatic disease, severe psychological disorders, or those who have had recent arm infections or surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of photobiomodulation therapy (PBMT) combined with manual lymphatic drainage for managing breast cancer-related lymphedema (BCRL). It aims to reduce arm circumference, alleviate pain, and improve the quality of life for patients suffering from BCRL. Participants will undergo PBMT and manual lymphatic drainage, with assessments conducted during treatment and up to 12 months post-treatment. The study focuses on patients who have undergone breast cancer surgery and are experiencing lymphedema.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of lymphedema, enhancing patients' quality of life and reducing discomfort.
How similar studies have gone: While the use of PBMT is gaining interest, this specific combination of PBMT with manual lymphatic drainage for BCRL is relatively novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hasselt University
Hasselt, Limburg, Belgium Recruiting -
Jessa Ziekenhuis
Hasselt, Limburg, Belgium Recruiting
Study contacts
- Principal investigator: Jeroen Mebis, MD, PhD — Jessa Hospital
- Study coordinator: Jolien Robijns, PhD
- Email: jolien.robijns@jessazh.be
- Phone: 011337229
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Program to prevent lymphedema after breast cancer surgery
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.