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)

April 6, 2021 updated by: Institut Claudius Regaud

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Institut Universitaire Du Cancer de Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Basic Oral Care + active LLLT (experimental arm)
Device: Basic Oral Care + active LLLT
  • Compliance with the Basic Oral Care Associated with
  • Active LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)
PLACEBO_COMPARATOR: Basic oral Care + inactive LLLT (control arm)
Other: Basic oral Care + inactive LLLT
  • Compliance with the Basic Oral Care Associated with
  • Inactive LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)
OTHER: Basic Oral Care (control arm)
Other: Basic Oral Care
Compliance with the Basic Oral Care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
16 days for each patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores
Time Frame: 16 days for each patient
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
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
16 days for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (ACTUAL)

May 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19 VADS 04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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