Oral MucositisPEDIALASENCT02604329
Feasibility Study of a Protocol to Treat Pediatric Oral Mucositis by Low-level Laser Therapy
A study testing "Oncolase Digi" therapy laser diode in people with Oral Mucositis, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- "Oncolase Digi" therapy laser diode
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to 14 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy
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.
Read the 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).
- Conditions
- Oral Mucositis
- Being tested
- "Oncolase Digi" therapy laser diode
- Keywords
- low level laser therapy, oral mucositis, child
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Oncolase Digi" therapy laser diodeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Radiation : use of "Oncolase Digi" therapy laser diode Receives: Device: "Oncolase Digi" therapy laser diode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (6)
Evaluation of mucositis grade
The World Health Organization (WHO) mucositis grade, before and after each laser application
Measured: 7 days
Evaluation of the number of laser treatment sessions
Evaluation of the number of laser treatment sessions related to the mucositis episode
Measured: 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")
Measured: 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
Measured: 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.
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle NOIRRIT-ESCLASSAN, PHD; DDS, Principal investigator, Toulouse Children University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604329
- Sponsor's protocol ID
- RC31/14/7421
- Acronym
- PEDIALASE
- Status last verified
- May 2018
- First submitted
- 20 Oct 2015
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Noirrit-Esclassan E, Valera MC, Vignes E, Munzer C, Bonal S, Daries M, Vaysse F, Puiseux C, Castex MP, Boulanger C, Pasquet M. Photobiomodulation with a combination of two wavelengths in the treatment of oral mucositis in children: The PEDIALASE feasibility study. Arch Pediatr. 2019 Jul;26(5):268-274. doi: 10.1016/j.arcped.2019.05.012. Epub 2019 Jul 4.
PubMed 31281038
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Treatment Protocol of Pediatric Chemo- and Radiotherapy-induced Oral Mucositis by Low-level Laser Therapy
- ClinicalTrials.gov ID
- NCT02604329
- Acronym / sponsor ID
- PEDIALASE / RC31/14/7421
- Conditions
- Oral Mucositis
- Keywords
- low level laser therapy, oral mucositis, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: "Oncolase Digi" therapy laser diodeRadiation : use of "Oncolase Digi" therapy laser diode |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Oncolase Digi" therapy laser diodeThe 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. | Device | intervention |
Primary outcome
Success of the procedure for each included child
Time frame: 7 days
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
Time frame: 1 year
Number of included patients related to the number of patients hospitalized for mucositis with a WHO grade of 2 or more, in one year.
6 secondary outcomes
Evaluation of mucositis grade
Time frame: 7 days
Evaluation of the number of laser treatment sessions
Time frame: 7 days
Pain evaluation with the HEDEN mucositis pain scale
Time frame: 7 days
Efficacy of low level laser therapy in the treatment of oral mucositis of grade 2
Time frame: 7 days
Pain evaluation with the Venham scale
Time frame: 7 days
Evaluation of medical time needed for the treatment
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 31281038Noirrit-Esclassan E, Valera MC, Vignes E, Munzer C, Bonal S, Daries M, Vaysse F, Puiseux C, Castex MP, Boulanger C, Pasquet M. Photobiomodulation with a combination of two wavelengths in the treatment of oral mucositis in children: The PEDIALASE feasibility study. Arch Pediatr. 2019 Jul;26(5):268-274. doi: 10.1016/j.arcped.2019.05.012. Epub 2019 Jul 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle NOIRRIT-ESCLASSAN, PHD; DDS principal investigator
Toulouse Children University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Oncolase Digi" therapy laser diode in people with Oral Mucositis, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of the procedure for each included child (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.