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NCT Number: NCT02604329

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

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.

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Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Toulouse

Toulouse, 31059, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"Oncolase Digi" therapy laser diode

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.

Primary outcomes

  1. Success of the procedure for each included child

    Time frame: 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.

  2. Participation rate

    Time frame: 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.

Secondary outcomes

  1. Evaluation of mucositis grade

    Time frame: 7 days

    The World Health Organization (WHO) mucositis grade, before and after each laser application

  2. Evaluation of the number of laser treatment sessions

    Time frame: 7 days

    Evaluation of the number of laser treatment sessions related to the mucositis episode

  3. Pain evaluation with the HEDEN mucositis pain scale

    Time frame: 7 days

    Pain evaluation by medical caregivers with the HEDEN mucositis pain scale ("Hétero Evaluation Douleur Enfant")

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

    Time frame: 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

  5. Pain evaluation with the Venham scale

    Time frame: 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.

  6. Evaluation of medical time needed for the treatment

    Time frame: 7 days

    Evaluation of the time spent with the patients for the treatment of oral mucositis by the medical staff

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy

Acronym: PEDIALASE

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2015
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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