Clinical trial · Interventional
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer
A Randomized, Double Blind, Controlled, Multi-center, Phase III Study to Assess Efficacy of Low Level Diode Laser (100 MW, 658 Nm), in the Prevention and Treatment of Radiochemotherapy-induced Mucositis in Head and Neck Cancer.
- 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 the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.
Conditions
Conditions (4)
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 | — |
| Oral Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Hypopharynx | Hypopharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma of Oropharynx | Oropharyngeal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| low level laser therapy | Procedure | — | UNRESOLVED |
| placebo (laser low level energy nonfunctional) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- laser low-level energy functional
- description
- The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus.
- type
- PLACEBO_COMPARATOR
- label
- laser low-level energy nonfunctional
- description
- The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute.
Primary outcomes (1)
- measure
- Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification
- timeFrame
- Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 75 years 2. Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed 3. PS \> or = 2 4. Estimated life expectancy greater than 3 months in the absence of treatment 5. Concomitant chemotherapy with one of the following choices not prohibited: * Cetuximab alone * 5-FU combined to Carboplatin or Cisplatin * Cisplatin alone Being defined as follows: serum creatinine \< 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the Cockcroft method) in case of serum creatinine \> 120 µmol/l 6. Appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results: * Hemoglobin\> 8g/dL * Neutrophils\> 1500 x 109 / L * Platelets\> 100 x 109 / l * Total bilirubin \<1.5 times the upper limit of normal * ALT / AST and alkaline phosphatase \<2.5 times the upper limit of normal. 7. For women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required. Exclusion Criteria: 1. Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix 2. Neoadjuvant chemotherapy 3. Metastatic disease 4. Previous treatment with ENT radiotherapy 5. Severe hypersensitivity known to platinum based agent 6. Any uncontrolled pathology (respiratory, cardiac, hepatic or renal) 7. Pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
References
Publications (1)
- DERIVEDLegoute F, Bensadoun RJ, Seegers V, Pointreau Y, Caron D, Lang P, Prevost A, Martin L, Schick U, Morvant B, Capitain O, Calais G, Jadaud E. Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial. Radiat Oncol. 2019 May 22;14(1):83. doi: 10.1186/s13014-019-1292-2. PMID 31118057