Clinical trial · Interventional
Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients
Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck 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)
Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD). Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in head and neck cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head Cancer | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
| Neck Cancer | Malignant Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-level laser therapy | Device | — | UNRESOLVED |
| sham laser | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Control group
- description
- Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
- interventionNames
- Device: sham laser
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
- interventionNames
- Device: Low-level laser therapy
Primary outcomes (6)
- measure
- Radiation Dermatitis Grade
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx * Scheduled for radiotherapy (\>60 Gy), chemo-irradiation or bio-radiation either as primary or as post-operative treatment to the head and neck region * Age ≥ 18 years * Able to comply to the study protocol * Able to sign written informed consent * Signed written informed consent Exclusion Criteria: * Previous irradiation to the head and/or neck region * Metastatic disease * Patients with pre-existing skin rash, ulceration or open wound in the treatment area * Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields * Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator * Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator * Patients using high doses of non-steroidal anti-inflammatory drugs
References
Publications (0)
Data not yet available