Clinical trial NCT02604329: Feasibility Study of a Protocol to Treat Pediatric Oral Mucositis by Low-level Laser Therapy
Official title: Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Keywords: low level laser therapy
oral mucositis
child
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Success of the procedure for each included child
timeFrame: 7 days
measure: Participation rate
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of mucositis grade
timeFrame: 7 days
measure: Evaluation of the number of laser treatment sessions
timeFrame: 7 days
measure: Pain evaluation with the HEDEN mucositis pain scale
timeFrame: 7 days
measure: Efficacy of low level laser therapy in the treatment of oral mucositis of grade 2
timeFrame: 7 days
measure: Pain evaluation with the Venham scale
timeFrame: 7 days
measure: Evaluation of medical time needed for the treatment
timeFrame: 7 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UH Toulouse
Study officials:
affiliation: Toulouse Children University Hospital
name: Emmanuelle NOIRRIT-ESCLASSAN, PHD; DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qutob AF, Gue S, Revesz T, Logan RM, Keefe D. Prevention of oral mucositis in children receiving cancer therapy: a systematic review and evidence-based analysis. Oral Oncol. 2013 Feb;49(2):102-7. doi: 10.1016/j.oraloncology.2012.08.008. Epub 2012 Sep 7.
citation: Sonis ST. Oral mucositis in head and neck cancer: risk, biology, and management. Am Soc Clin Oncol Educ Book. 2013. doi: 10.14694/EdBook_AM.2013.33.e236.
citation: Glenny AM, Gibson F, Auld E, Coulson S, Clarkson JE, Craig JV, Eden OB, Khalid T, Worthington HV, Pizer B; Children's Cancer and Leukaemia Group (CCLG)/Paediatric Oncology Nurses Forum's (CCLG-PONF) Mouth Care Group. The development of evidence-based guidelines on mouth care for children, teenagers and young adults treated for cancer. Eur J Cancer. 2010 May;46(8):1399-412. doi: 10.1016/j.ejca.2010.01.023. Epub 2010 Mar 11.
citation: Huang YY, Sharma SK, Carroll J, Hamblin MR. Biphasic dose response in low level light therapy - an update. Dose Response. 2011;9(4):602-18. doi: 10.2203/dose-response.11-009.Hamblin. Epub 2011 Sep 2.
citation: Bensadoun RJ, Nair RG. Low-level laser therapy in the prevention and treatment of cancer therapy-induced mucositis: 2012 state of the art based on literature review and meta-analysis. Curr Opin Oncol. 2012 Jul;24(4):363-70. doi: 10.1097/CCO.0b013e328352eaa3.