Clinical trial · Interventional
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Phase III Trial of Low-level Laser Therapy to Prevent Induced Oral Mucositis in Head and Neck Cancer Patients Submitted to Concurrent Chemoradiation
- 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)
Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma of Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Nasopharynx | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low Level Laser Therapy- (DMC, São Paulo, Brazil) | Device | — | UNRESOLVED |
| Placebo (DMC, São Paulo, Brazil) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
- interventionNames
- Device: Placebo (DMC, São Paulo, Brazil)
- type
- EXPERIMENTAL
- label
- Low Level Laser Therapy
- description
- The investigators used a Low Level Laser Therapy, diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
- interventionNames
- Device: Low Level Laser Therapy- (DMC, São Paulo, Brazil)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histological diagnosis of squamous cell carcinoma (nasopharynx, oropharynx and hypopharynx) * Candidates for surgery or treatment for organ preservation * Performance status (PS) of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) * Indication for radiotherapy and concurrent platinum-based chemotherapy * Oral mucosa intact * Agree to follow the protocol of oral hygiene * Informed consent. Exclusion Criteria: * Patients using medication for treatment and or prevention of mucositis * Patients incapable of treatment compliance or of performing the protocol of oral hygiene
References
Publications (1)
- DERIVEDAntunes HS, Schluckebier LF, Herchenhorn D, Small IA, Araujo CM, Viegas CM, Rampini MP, Ferreira EM, Dias FL, Teich V, Teich N, Ferreira CG. Cost-effectiveness of low-level laser therapy (LLLT) in head and neck cancer patients receiving concurrent chemoradiation. Oral Oncol. 2016 Jan;52:85-90. doi: 10.1016/j.oraloncology.2015.10.022. Epub 2015 Nov 11. PMID 26559740