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

Institut Claudius Regaud

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Upper Aerodigestive Tract Neoplasms

Interventions

Basic Oral Care + active LLLTDEVICE

* Compliance with the Basic Oral Care Associated with * Active LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)

Basic oral Care + inactive LLLTOTHER

* Compliance with the Basic Oral Care Associated with * Inactive LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)

Basic Oral CareOTHER

Compliance with the Basic Oral Care only

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Outcomes

Primary Outcomes

Rate of patients who didn't need a dose increase or introduction of new analgesics for mouth pain during the study compared to baseline

Time frame: 16 days for each patient

Secondary Outcomes

Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores

Time frame: 16 days for each patient

Quality of Life assessed by the Quality of Life Questionnaire specific to Head and Neck cancer (H&N35)

Time frame: 16 days for each patient

Frequency of adverse events related to the LLLT using the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 5.0

Time frame: 16 days for each patient

Data from ClinicalTrials.gov

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