An interventional study of "Oncolase Digi" therapy laser diode in Oral Mucositis, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Supportive care
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.
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).
400 studies on the registry are indexed under Stomatitis; 83 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 349 interventional studies indexed under Stomatitis.
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Exclusion Criteria:
Radiation : use of "Oncolase Digi" therapy laser diode
Device: "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.
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.
Time frame: 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.
Time frame: 1 year
Evaluation of mucositis grade
The World Health Organization (WHO) mucositis grade, before and after each laser application
Time frame: 7 days
Evaluation of the number of laser treatment sessions
Evaluation of the number of laser treatment sessions related to the mucositis episode
Time frame: 7 days
Pain evaluation with the HEDEN mucositis pain scale
Pain evaluation by medical caregivers with the HEDEN mucositis pain scale ("Hétero Evaluation Douleur Enfant")
Time frame: 7 days
Efficacy of low level laser therapy in the treatment of oral mucositis of grade 2
Efficacy of low level laser therapy will be evaluate by medical caregivers with VAS (Visual Analogic Scale), before and after each laser application
Time frame: 7 days
Pain evaluation with the Venham scale
By medical caregiver delivering the laser treatment with the Venham scale modified by Veerkamp and OPS (Objective Pain Scale) for children under 6.
Time frame: 7 days
Evaluation of medical time needed for the treatment
Evaluation of the time spent with the patients for the treatment of oral mucositis by the medical staff
Time frame: 7 days
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse