Clinical trial · Interventional
Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Study in Patients With Upper Aerodigestive Tract Cancer
Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Phase II Randomized Study in Patients With Upper Aerodigestive Tract Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to lack of recruitment
Summary
Brief summary (as posted)
Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy. Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment. The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days. Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.
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 |
|---|---|---|---|
| Upper Aerodigestive Tract Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Basic Oral Care | Other | — | UNRESOLVED |
| Basic Oral Care + active LLLT | Device | — | UNRESOLVED |
| Basic oral Care + inactive LLLT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Basic Oral Care + active LLLT (experimental arm)
- interventionNames
- Device: Basic Oral Care + active LLLT
- type
- PLACEBO_COMPARATOR
- label
- Basic oral Care + inactive LLLT (control arm)
- interventionNames
- Other: Basic oral Care + inactive LLLT
- type
- OTHER
- label
- Basic Oral Care (control arm)
- interventionNames
- Other: Basic Oral Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients with upper aero-digestive tract cancer receiving a first cervicofacial radiotherapy or chemoradiotherapy 3. Patients with a grade 2 mucositis (according to the NCI CTCAE version 5.0) appearing during treatment. 4. Patients available to perform the LLLT treatment: 5 visits at 3 days intervals 5. Patients must provide written informed consent prior to any study specific procedures. 6. Patients affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Patients who have already received a cervicofacial radiotherapy 2. Patients who have already received an induction chemotherapy for their upper aero-digestive tract cancer 3. Patients under targeted therapy for their upper aero-digestive tract cancer 4. Patients under systemic corticotherapy 5. Patients with a non-grade 2 mucositis (according to the NCI CTCAE version 5.0) 6. Patients with ulceration or any other oral mucosa pathology than mucositis 7. Pregnant or breastfeeding women 8. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure 9. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
References
Publications (0)
Data not yet available