CompletedNot Applicable

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

France22 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range3 Years – 16 Years

SexALL

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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.

What they're measuring

Success of the procedure for each included child

Timeframe: 7 days

Participation rate

Timeframe: 1 year

Trial details

NCT IDNCT02604329

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-14

View on ClinicalTrials.gov More Oral Mucositis trials