ESMULLLAT: 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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03955224

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Aerodigestive Tract Neoplasms	Device: Basic Oral Care + active LLLT Other: Basic oral Care + inactive LLLT Other: Basic Oral Care	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of patients who didn't need a dose increase or introduction of new analgesics for mouth pain during the study compared to baseline [16 days for each patient]

Secondary Outcome Measures

Evaluation of the oral mucositis pain intensity with Visual Analog Scale Scores [16 days for each patient]
Quality of Life assessed by the Quality of Life Questionnaire specific to Head and Neck cancer (H&N35) [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 [16 days for each patient]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)