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 (ESMULLLAT)

Institut Claudius Regaud

Status and phase: Withdrawn; Phase 2

Conditions: Upper Aerodigestive Tract Neoplasms

Treatments: Other: Basic oral Care + inactive LLLT; Device: Basic Oral Care + active LLLT; Other: Basic Oral Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03955224

19 VADS 04

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

Basic Oral Care + active LLLT (experimental arm)

Active Comparator group

Treatment:

Device: Basic Oral Care + active LLLT

Basic oral Care + inactive LLLT (control arm)

Placebo Comparator group

Treatment:

Other: Basic oral Care + inactive LLLT

Basic Oral Care (control arm)

Other group

Treatment:

Other: Basic Oral Care