NCT02604329

Brief Summary

Low Level Laser Therapy has been used for a few years in some pediatric hospital centers for chemo- and radiotherapy-induced oral mucositis care. It may promote ulceration's healing, limits mucositis severity and associated pain. As its use is recommended in the treatment of radio induced mucositis in adults, the level of evidence in pediatric studies does not allow a precise treatment protocol. The investigators present here the protocol of a feasibility study in the haemato-oncology department of the Children University Hospital of Toulouse, with the view to a future efficacy study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

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

October 20, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2017

Completed
Last Updated

December 10, 2025

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

October 20, 2015

Last Update Submit

December 2, 2025

Conditions

Oral Mucositis

Keywords

low level laser therapyoral mucositischild

Outcome Measures

Primary Outcomes (2)

  • Success of the procedure for each included child

    The procedure is successful when low level laser has been used on all the oral mucosa minimum 3 times in the first 7 days of mucositis of grade 2. The failure of the procedure is therefore declared if the laser was applied within 3 times within 7 days.

    7 days

  • Participation rate

    Number of included patients related to the number of patients hospitalized for mucositis with a WHO grade of 2 or more, in one year.

    1 year

Secondary Outcomes (6)

  • Evaluation of mucositis grade

    7 days

  • Evaluation of the number of laser treatment sessions

    7 days

  • Pain evaluation with the HEDEN mucositis pain scale

    7 days

  • Efficacy of low level laser therapy in the treatment of oral mucositis of grade 2

    7 days

  • Pain evaluation with the Venham scale

    7 days

  • +1 more secondary outcomes

Study Arms (1)

intervention

EXPERIMENTAL

Radiation : use of "Oncolase Digi" therapy laser diode

Device: "Oncolase Digi" therapy laser diode

Interventions

"Oncolase Digi" therapy laser diodeDEVICE

The athermic phototherapy laser diode will be used by scanning the entire oral mucosa, including cheek and lip mucosa, gums, palate, tongue and floor of the mouth. It will be applied uniformly every two days as long as the grade of mucositis is 2 or more, with a fluence of 4J/cm², under two wavelengths (635 nm and 815 nm). * Cheeks will be scanned extra-orally with laser fiber during 50 seconds, at the fluence of 4J/cm², associating two wavelengths : infra-red (815 nm, 3850mW) and red (635 nm, 150mW). * Intra-orally, the fiber will be used to scan each area of mucositis during 30 seconds per area of 2 cm2, at 1cm from the mucosa; the power at 635 nm will be 150 milliwatts and 150 milliwatts at 815 nm.

intervention

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hospitalization in the oncology ward of the university hospital Toulouse France
  • Onco-haematological paediatric patients treated by radio- and /or chemo-therapy, affected by an oral mucositis of WHO grade 2 to 4,
  • lack of any physical or psychological disease which could interfere with the realization of the study.

You may not qualify if:

  • Onco-haematological paediatric patients treated by radio- and /or chemo-therapy, affected by an oral mucositis of WHO's grade under 2
  • Child suffering from epilepsy
  • Patient wearing a cardiac pacemaker
  • Patient not able to open their mouth at least 20 mm
  • Patient refusing the wearing of safety goggles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

  • Noirrit-Esclassan E, Valera MC, Vignes E, Munzer C, Bonal S, Daries M, Vaysse F, Puiseux C, Castex MP, Boulanger C, Pasquet M. Photobiomodulation with a combination of two wavelengths in the treatment of oral mucositis in children: The PEDIALASE feasibility study. Arch Pediatr. 2019 Jul;26(5):268-274. doi: 10.1016/j.arcped.2019.05.012. Epub 2019 Jul 4.

    PMID: 31281038RESULT

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Emmanuelle NOIRRIT-ESCLASSAN, PHD; DDS

    Toulouse Children University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

November 13, 2015

Study Start

December 1, 2015

Primary Completion

February 14, 2017

Study Completion

February 14, 2017

Last Updated

December 10, 2025

Record last verified: 2018-05

Locations

FR(1)