Feasibility Study of a Protocol to Treat Pediatric Oral Mucositis by Low-level Laser Therapy

Not Applicable

Completed

• Conditions: Oral Mucositis
• Interventions: Device: "Oncolase Digi" therapy laser diode

• Registration Number: NCT02604329
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

This study aims to evaluate the feasibility of using low level laser therapy (LLLT) in the haemato-oncology department of the Children University Hospital of Toulouse. The feasibility will be considered as acceptable if 60% of patients hospitalized for oral mucositis had successfully benefit from the procedure. The secondary objectives are the evaluation of efficacy of LLLT on pain and mucositis grade, the evaluation of tolerance of this treatment and the medical time needed for this supportive care. The athermic phototherapy laser diode will be used by scanning the entire oral mucosa area. It will be applied uniformly every two days as long as grade of mucositis is 2 or more, with a fluence of 4J/cm², under two wavelengths (635 nm and 815 nm).

Study Timeline

• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-11-12
• Study First Posted: 2015-11-13
• Study Start: 2015-12
• Primary Completion: 2017-02-14
• Study Completion: 2017-02-14
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	"Oncolase Digi" therapy laser diode	Radiation : use of "Oncolase Digi" therapy laser diode

Primary Outcome Measures

Name	Time	Method
Participation rate	1 year	Number of included patients related to the number of patients hospitalized for mucositis with a WHO grade of 2 or more, in one year.
Success of the procedure for each included child	7 days	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.

Secondary Outcome Measures

Name	Time	Method
Pain evaluation with the HEDEN mucositis pain scale	7 days	Pain evaluation by medical caregivers with the HEDEN mucositis pain scale ("Hétero Evaluation Douleur Enfant")
Evaluation of medical time needed for the treatment	7 days	Evaluation of the time spent with the patients for the treatment of oral mucositis by the medical staff
Efficacy of low level laser therapy in the treatment of oral mucositis of grade 2	7 days	Efficacy of low level laser therapy will be evaluate by medical caregivers with VAS (Visual Analogic Scale), before and after each laser application
Pain evaluation with the Venham scale	7 days	By medical caregiver delivering the laser treatment with the Venham scale modified by Veerkamp and OPS (Objective Pain Scale) for children under 6.
Evaluation of mucositis grade	7 days	The World Health Organization (WHO) mucositis grade, before and after each laser application
Evaluation of the number of laser treatment sessions	7 days	Evaluation of the number of laser treatment sessions related to the mucositis episode

Trial Locations

Locations (1)

UH Toulouse; 🇫🇷 Toulouse, France