Clinical trial · Interventional
Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema
Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Related Lymphedema | — | UNRESOLVED | — |
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Manual Lymphatic drainage | Procedure | — | UNRESOLVED |
| Photobiomodulation therapy (PBMT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Group A will receive first PBM + manual lymphatic drainage for 9 weeks (2 sessions/week), followed by 9 weeks only manual lymphatic drainage.
- interventionNames
- Device: Photobiomodulation therapy (PBMT)
- Procedure: Manual Lymphatic drainage
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- Group B will first receive only manual lymphatic drainage for 9 weeks, followed by the combination of PBM and manual lymphatic drainage for 9 weeks (2x/week).
- interventionNames
- Device: Photobiomodulation therapy (PBMT)
- Procedure: Manual Lymphatic drainage
Primary outcomes (34)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available