NCT03955224

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 8, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

May 16, 2019

Last Update Submit

April 6, 2021

Conditions

Upper Aerodigestive Tract Neoplasms

Keywords

Upper Aerodigestive Tract NeoplasmsLow-Level Laser Therapy (LLLT)Mucositis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

Basic Oral Care + active LLLT (experimental arm)

ACTIVE COMPARATOR
Device: Basic Oral Care + active LLLT

Basic oral Care + inactive LLLT (control arm)

PLACEBO COMPARATOR
Other: Basic oral Care + inactive LLLT

Basic Oral Care (control arm)

OTHER
Other: Basic Oral Care

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 + active LLLT (experimental arm)
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 Care + inactive LLLT (control arm)
Basic Oral CareOTHER

Compliance with the Basic Oral Care only

Basic Oral Care (control arm)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsMucositis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 20, 2019

Study Start

March 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

April 8, 2021

Record last verified: 2021-03

Locations

FR(1)