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

Oral Mucositis Clinical Trial

— PEDIALASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604329
• Other study ID #: RC31/14/7421
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: February 14, 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 14, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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.

Locations

Country	Name	City	State
France	UH Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (5)

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. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation

Sonis ST. Oral mucositis in head and neck cancer: risk, biology, and management. Am Soc Clin Oncol Educ Book. 2013. doi: 10.1200/EdBook_AM.2013.33.e236. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Primary	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.	1 year
Secondary	Evaluation of mucositis grade	The World Health Organization (WHO) mucositis grade, before and after each laser application	7 days
Secondary	Evaluation of the number of laser treatment sessions	Evaluation of the number of laser treatment sessions related to the mucositis episode	7 days
Secondary	Pain evaluation with the HEDEN mucositis pain scale	Pain evaluation by medical caregivers with the HEDEN mucositis pain scale ("Hétero Evaluation Douleur Enfant")	7 days
Secondary	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	7 days
Secondary	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.	7 days
Secondary	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	7 days