NCT04596410

Brief Summary

Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia. Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines. Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
406

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

16 active sites

Status
unknown

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

September 4, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

May 3, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2.7 years

First QC Date

September 4, 2020

Last Update Submit

September 20, 2023

Conditions

Mucositis Oral

Keywords

ChildrenOral mucositisChemotherapyPhotobiomodulation

Outcome Measures

Primary Outcomes (1)

  • Session evaluation

    Duration (in days) from the day of first PBM session up to the day of first measurement when patient has no longer WHO grade 2 or higher chemotherapy-induced OM related pain at 2 consecutive measurements before the next scheduled PBM session (either active laser application or matching placebo application)

    Throught treatment period up to 1 month

Secondary Outcomes (10)

  • Production costs evaluation

    2 months

  • Health insurance evaluation

    2 months

  • OM duration evaluation

    Throught treatment period up to 1 month

  • OM occurrence

    2 months

  • Feed evaluation

    2 months

  • +5 more secondary outcomes

Study Arms (2)

LLLT applied every other day

EXPERIMENTAL

Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day

Radiation: LLLT applied every other day

LLLT applied daily

ACTIVE COMPARATOR

Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every day

Radiation: LLLT applied daily

Interventions

LLLT applied every other dayRADIATION

Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day

LLLT applied every other day
LLLT applied dailyRADIATION

Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily

LLLT applied daily

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female children aged ≥ 3 years and \< 18 years.
  • Hospitalization in an oncology or hematology department in the participating centres.
  • Patients with oropharyngeal mucositis of grade 2 or higher (WHO grading system) related to cancer chemotherapy, including conditioning for Hematopoietic Stem Cell Transplantation (HSCT).
  • Written informed consent of both patient's holders of parental authority, and patient's assent when applicable.
  • Patients affiliated to a French Social Security insurance or equivalent social protection.
  • Absence of any physical or psychological disability that may interfere with the LLLT application.

You may not qualify if:

  • Patients with a solid cancer lesion in the area of low-level laser application.
  • History of cervicofacial radiotherapy.
  • Application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization.
  • Patients susceptible to epilepsy seizure.
  • Patients with pacemaker.
  • Patients refusing to wear retinal goggles during low-level laser 1. Patients with a solid cancer lesion in the area of low-level laser application.
  • Patients protected by law (guardianship and safeguarding of justice).
  • Pregnant female patients as determined by positive serum pregnancy test at screening.
  • Lactating female patients who are actively breast feeding.
  • Participation in another clinical trial involving oral care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

University hospital of Toulouse

Toulouse, Occitanie, 31000, France

RECRUITING

University hospital of Angers

Angers, France

RECRUITING

University hospital of Besançon

Besançon, France

RECRUITING

University hospital of Grenoble

Grenoble, France

RECRUITING

University hospital of Lille

Lille, France

RECRUITING

University hospital of Limoges

Limoges, France

RECRUITING

Hôpital La Timone

Marseille, France

RECRUITING

University hospital of Nancy

Nancy, France

RECRUITING

University Hospital of Nice

Nice, France

RECRUITING

Armand Trousseau Hospital

Paris, France

RECRUITING

University hospital of Poitiers

Poitiers, France

RECRUITING

University hospital of Reims

Reims, France

RECRUITING

University hospital of Rouen

Rouen, France

RECRUITING

University hospital of Saint-Etienne

Saint-Etienne, France

RECRUITING

University hospital of Strasbourg

Strasbourg, France

RECRUITING

University Hospital of Tours

Tours, France

RECRUITING

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Marlène PASQUET

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlène PASQUET, MD

CONTACT

05 34 55 86 43pasquet.m@chu-toulouse.fr

Gwennaëlle ALPHONSA, CRA

CONTACT

05 67 77 13 94alphonsa.g@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

October 22, 2020

Study Start

May 3, 2021

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

FR(16)