Clinical trial · Interventional
Photobiomodulation for Breast Cancer Radiodermatitis
Photobiomodulation for Breast Cancer Radiodermatitis Prevention. A Randomized Controlled Trial.
NCT04059809CI-TRIAL-00053257completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
A prospective single blind controlled randomized trial to evaluate the superiority of photobiomodulation (PBM) using LED-therapy in reducing the prevalence of radiodermatitis in breast cancer compared to usual local care.
Conditions
Conditions (8)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Quality of Life | — | UNRESOLVED | — |
| Radiation Dermatitis | — | UNRESOLVED | — |
| Radiation Injuries | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Radiodermatitis | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photobiomodulation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- The control group will have usual care according to the orientation of the radiation therapy faculty responsible for the radiotherapy treatment the PBM device will be switched off
- type
- EXPERIMENTAL
- label
- Photobiomodulation (PBM)
- description
- Additionally to the usual care, the patients will receive the PBM. Treatment will be done twice a week.
- interventionNames
- Device: Photobiomodulation
Primary outcomes (2)
- measure
- Grade of Radiodermatitis
- timeFrame
- During radiation treatment
- description
- "Radiation Therapy Oncology Group" (RTOG) grading
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer * Mastectomy or breast conserving surgery * Informed consent * Radiotherapy schedule completion Exclusion Criteria: * Auto-immune disorders * Immediate reconstruction
References
Publications (0)
Data not yet available
No reference posted for this study.