Clinical trial · Interventional
Effectiveness of Low Energy Laser Treatment in Oral Mucositis Induced by Chemotherapy and Radiotherapy in Head and Neck Cancer
NCT01876407CI-TRIAL-00020802unknownPhase 4ClinicalTrials.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)
The purpose of this study is to evaluate the effectiveness of using to low intensity laser as an intervention against preventive and therapeutic oral mucositis induced by radiotherapy and chemotherapy.
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 |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low intensity laser for oral mucositis | Device | — | UNRESOLVED |
| Low intensity laser for oral mucositis switch off | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low energy laser
- description
- Administration of a low energy laser for oral mucositis.
- interventionNames
- Device: Low intensity laser for oral mucositis
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Device: Low intensity laser for oral mucositis switch off
Primary outcomes (1)
- measure
- Evaluate the effectiveness of using low-intensity laser compared with placebo as preventive and therapeutic intervention of oral mucositis induced by radiation therapy and chemotherapy.
- timeFrame
- 24 months
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with squamous cell carcinoma of the oral cavity. * Patients aged between 18 and 80 years. * Patients who are to receive one of the following treatment * Combined radiotherapy (conventional fractionation 70 Gy reaching the tumor and affected lymph nodes, and 50 Gy in the areas ganglion drainage) and chemotherapy (cisplatin 100 mg/m2 IV on days 1, 22 and 43 irradiation or cetuximab 400mg/m2 as a single dose pre-load radiotherapy and 250mg/m2 weekly for the same. Regardless of whether they have received previous surgical treatment. * Treatment with radiotherapy of 70 Gy in 35 daily sessions 2Gy/día consecutive. * Patients who voluntarily express their intention to participate by informed consent. Exclusion Criteria: * Patients who denied informed consent. * Patients who have hypersensitivity or allergy to any of the components included in the study. * Patients diagnosed with HIV, and autoimmune diseases.
References
Publications (0)
Data not yet available
No reference posted for this study.