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

NCT ID: NCT02604329

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-02-14

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).

Conditions

Oral Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intervention

Radiation : use of "Oncolase Digi" therapy laser diode

Group Type: EXPERIMENTAL

"Oncolase Digi" therapy laser diode

Intervention Type: DEVICE

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.

Interventions

"Oncolase Digi" therapy laser diode

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 Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle NOIRRIT-ESCLASSAN, PHD; DDS

Role: PRINCIPAL_INVESTIGATOR

Toulouse Children University Hospital

Locations

UH Toulouse

Toulouse, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 31281038 (View on PubMed)

Other Identifiers

RC31/14/7421

Identifier Type: -

Identifier Source: org_study_id