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Withdrawn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
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Toulouse, France
- Institut Universitaire du Cancer de Toulouse - Oncopole
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-
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:
- Age ≥ 18 years.
- Patients with upper aero-digestive tract cancer receiving a first cervicofacial radiotherapy or chemoradiotherapy
- Patients with a grade 2 mucositis (according to the NCI CTCAE version 5.0) appearing during treatment.
- Patients available to perform the LLLT treatment: 5 visits at 3 days intervals
- Patients must provide written informed consent prior to any study specific procedures.
- Patients affiliated to a Social Health Insurance in France.
Exclusion Criteria:
- Patients who have already received a cervicofacial radiotherapy
- Patients who have already received an induction chemotherapy for their upper aero-digestive tract cancer
- Patients under targeted therapy for their upper aero-digestive tract cancer
- Patients under systemic corticotherapy
- Patients with a non-grade 2 mucositis (according to the NCI CTCAE version 5.0)
- Patients with ulceration or any other oral mucosa pathology than mucositis
- Pregnant or breastfeeding women
- Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
- 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)
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PLACEBO_COMPARATOR: Basic oral Care + inactive LLLT (control arm)
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OTHER: Basic Oral Care (control arm)
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Compliance with the Basic Oral Care only
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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
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
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.