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

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"Oncolase Digi" therapy laser diode
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Mucositis focused on measuring low level laser therapy, oral mucositis, child

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UH Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention

Arm Description

Radiation : use of "Oncolase Digi" therapy laser diode

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Evaluation of mucositis grade
The World Health Organization (WHO) mucositis grade, before and after each laser application
Evaluation of the number of laser treatment sessions
Evaluation of the number of laser treatment sessions related to the mucositis episode
Pain evaluation with the HEDEN mucositis pain scale
Pain evaluation by medical caregivers with the HEDEN mucositis pain scale ("Hétero Evaluation Douleur Enfant")
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
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.
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

Full Information

First Posted
October 20, 2015
Last Updated
May 30, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02604329
Brief Title
Feasibility Study of a Protocol to Treat Pediatric Oral Mucositis by Low-level Laser Therapy
Acronym
PEDIALASE
Official Title
Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
February 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis
Keywords
low level laser therapy, oral mucositis, child

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
Radiation : use of "Oncolase Digi" therapy laser diode
Intervention Type
Device
Intervention Name(s)
"Oncolase Digi" therapy laser diode
Intervention Description
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 Outcome Measure Information:
Title
Success of the procedure for each included child
Description
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
Title
Participation rate
Description
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
Secondary Outcome Measure Information:
Title
Evaluation of mucositis grade
Description
The World Health Organization (WHO) mucositis grade, before and after each laser application
Time Frame
7 days
Title
Evaluation of the number of laser treatment sessions
Description
Evaluation of the number of laser treatment sessions related to the mucositis episode
Time Frame
7 days
Title
Pain evaluation with the HEDEN mucositis pain scale
Description
Pain evaluation by medical caregivers with the HEDEN mucositis pain scale ("Hétero Evaluation Douleur Enfant")
Time Frame
7 days
Title
Efficacy of low level laser therapy in the treatment of oral mucositis of grade 2
Description
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
Title
Pain evaluation with the Venham scale
Description
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
Title
Evaluation of medical time needed for the treatment
Description
Evaluation of the time spent with the patients for the treatment of oral mucositis by the medical staff
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle NOIRRIT-ESCLASSAN, PHD; DDS
Organizational Affiliation
Toulouse Children University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22959949
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.
Results Reference
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PubMed Identifier
23714511
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.
Results Reference
background
PubMed Identifier
20227272
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.
Results Reference
background
PubMed Identifier
22461763
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.
Results Reference
background
PubMed Identifier
22450151
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.
Results Reference
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Feasibility Study of a Protocol to Treat Pediatric Oral Mucositis by Low-level Laser Therapy

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