Clinical trial · Interventional
Laser Therapy for the Management of Radiation Dermatitis
Low-Level Laser Therapy for the Management of Radiation Dermatitis: A Pilot Study in Breast Cancer Patients
- 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)
Low Level Laser Therapy (LLLT) is a form of phototherapy which involves the application of light to injuries and lesions to promote tissue regeneration. It is a noninvasive treatment modality based on the photochemical effect of light on tissues, which modulates various metabolic processes. LLLT has been used for a wide range of conditions, in particular in dermatology, to promote wound healing, reduce inflammation and oedema, and relieve pain. In this study, we intend to assess the efficacy of LLLT to manage radiotherapy-induced skin reactions (or radiation dermatitis), a very common and distressing side effect of cancer treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-Level Laser Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Receives institutional skin care protocol
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Receives institutional skin care protocol and, when applicable (if skin reactions develop), Low-Level Laser Therapy
- interventionNames
- Device: Low-Level Laser Therapy
Primary outcomes (3)
- measure
- Radiation Dermatitis Grade
- timeFrame
- 3 months (during radiation therapy and one month after)
- description
- objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer (RTOG/ EORTC).
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of noninvasive (Stage 0) or invasive (Stages 1, 2 or 3A) breast adenocarcinoma * Treatment with primary breast-sparing surgery (lumpectomy) and/ or neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy or hormonal treatment * Scheduled for postoperative radiotherapy with standard technique (isocentric) and fractionation regime (i.e., 25 daily fractions to the whole breast followed by a boost of 8 fractions to the tumor bed, 2 Gy per fraction, five times per week) * Provide signed informed consent Exclusion Criteria: * Previous irradiation to the same breast * Metastatic disease * Mastectomy surgery * Concurrent chemo-radiotherapy * Required use of bolus material to deliver radiation therapy (i.e., material placed on the to-be-irradiated zone to modulate the delivered dose in order to ensure an optimal distribution of the radiation dose)
References
Publications (0)
Data not yet available