Status:
RECRUITING
Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema
Lead Sponsor:
Jessa Hospital
Collaborating Sponsors:
Hasselt University
Conditions:
Breast Cancer
Breast Cancer Related Lymphedema
Eligibility:
FEMALE
18+ years
Phase:
NA
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, heavine...
Detailed Description
This aim of this study is to determine the efficacy of PBMT in combination with the institutional therapy on the management of BCRL. Therefore, we hypothesize that PBMT in combination with manual lymp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04690439
Start Date
February 22 2021
End Date
February 1 2028
Last Update
February 28 2023
Active Locations (2)
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1
Hasselt University
Hasselt, Limburg, Belgium, 3500
2
Jessa Ziekenhuis
Hasselt, Limburg, Belgium, 3500