Mucositis OralCURALASE01NCT04596410
Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children
A study testing LLLT applied every other day and LLLT applied daily in people with Mucositis Oral, run by University Hospital, Toulouse at 16 sites in France.
Trial summary
Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia. Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Mucositis Oral
- What is being tested?
- LLLT applied every other day and LLLT applied daily
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 16 sitesFrance
- Study dates
- 3 May 2021to 22 May 2024
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female children aged ≥ 3 years and < 18 years.
- Hospitalization in an oncology or hematology department in the participating centres.
- Patients with oropharyngeal mucositis of grade 2 or higher (WHO grading system) related to cancer chemotherapy, including conditioning for Hematopoietic Stem Cell Transplantation (HSCT).
- Written informed consent of both patient's holders of parental authority, and patient's assent when applicable.
- Patients affiliated to a French Social Security insurance or equivalent social protection.
- Absence of any physical or psychological disability that may interfere with the LLLT application.
Who cannot join
- Patients with a solid cancer lesion in the area of low-level laser application.
- History of cervicofacial radiotherapy.
- Application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization.
- Hyperthyroidism defined by TSH < 0.4 IU/mL at inclusion.
- Patients susceptible to epilepsy seizure.
- Patients with pacemaker.
Show all 11Show fewer
- Patients refusing to wear retinal goggles during low-level laser 1. Patients with a solid cancer lesion in the area of low-level laser application.
- Patients protected by law (guardianship and safeguarding of justice).
- Pregnant female patients as determined by positive serum pregnancy test at screening.
- Lactating female patients who are actively breast feeding.
- Participation in another clinical trial involving oral care.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
University hospital of Angers
Angers
University hospital of Besançon
Besançon
University hospital of Grenoble
Grenoble
University hospital of Lille
Lille
University hospital of Limoges
Limoges
Hôpital La Timone
Marseille
University hospital of Nancy
Nancy
University Hospital of Nice
Nice
Armand Trousseau Hospital
Paris
University hospital of Poitiers
Poitiers
University hospital of Reims
Reims
University hospital of Rouen
Rouen
University hospital of Saint-Etienne
Saint-Etienne
University hospital of Strasbourg
Strasbourg
University hospital of Toulouse
Toulouse, Occitanie, 31000
University Hospital of Tours
Tours
About this study
Official title: Double-blind, Randomized, Multi-center, Non-inferiority Clinical Trial Comparing Two Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children
Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia.
Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines.
Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.
- Conditions
- Mucositis Oral
- Being tested
- LLLT applied every other day, LLLT applied daily
- Keywords
- Children, Oral mucositis, Chemotherapy, Photobiomodulation
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLLT applied every other dayRadiation
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day
LLLT applied dailyRadiation
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily
| Study group | Role | What they receive |
|---|---|---|
| LLLT applied every other day | Experimental | Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day Receives: Radiation: LLLT applied every other day |
| LLLT applied daily | Active comparator | Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every day Receives: Radiation: LLLT applied daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session evaluation
Duration (in days) from the day of first PBM session up to the day of first measurement when patient has no longer WHO grade 2 or higher chemotherapy-induced OM related pain at 2 consecutive measurements before the next scheduled PBM session (either active laser application or matching placebo application)
Measured: Throught treatment period up to 1 month
Secondary outcomes (10)
Production costs evaluation
Production costs from the hospital perspective and efficacy (i.e. number of days after which a child has no longer mucositis related pain as described in the primary endpoint section) to build Incremental Cost-Effectiveness Ratio (ICER) comparing every other day LLLT application versus with daily LLLT application.
Measured: 2 months
Health insurance evaluation
Costs of inpatient hospital stays from the French health insurance perspective.
Measured: 2 months
OM duration evaluation
Duration (in days) of chemotherapy-induced OM of WHO grade 2 or higher between the day of first PBM session up to the day of first measurement when patient has no longer WHO grade 2 or higher chemotherapy-induced OM at 2 consecutive measurements before the next scheduled PBM session (either every other day application or daily application).
Measured: Throught treatment period up to 1 month
OM occurrence
Occurrence of chemotherapy-induced OM of WHO grade 3 or 4 (deterioration of the clinical situation).
Measured: 2 months
Feed evaluation
Occurrence of enteral feeding.
Measured: 2 months
Analgesic consumption
Duration (in days) of consumption of step 2 and step 3 analgesics during chemotherapy-induced OM of WHO grade 2 or higher.
Measured: 2 months
PBM evaluation
Duration (in days) from the day of first PBM session up to the day of first measurement when patient has no longer WHO grade 2 or higher chemotherapy-induced OM related pain at 2 consecutive measurements before the next scheduled PBM session (either active laser application or matching placebo application) as evaluated, regardless of patient's age, with the ChIMES scale and use of step 3 analgesics.
Measured: Through treatment period up to 1 month
Pain change evaluation
Change over time in WHO grade 2 or higher chemotherapy-induced OM related pain, as assessed by pain scales (HEDEN (Hétero Evaluation Douleur Enfant) mucositis scale (5 items ranging from 0 to 2) or VAS (ranging from 0 to 10)depending on patient's age category, and Children's International Mucositis Evaluation Scale (4 items ranging from 0 to 5) whatever patient's age category)
Measured: From baseline to each day of PBM session
Adverse events occurrence
Occurrence of adverse events reported according to descriptions and grading scale found in NCI CTCAE version 5.0.
Measured: 2 months
thyroid-stimulating hormone (TSH) evolution
TSH shift from baseline value classified according to the following three categories: "< 0.4 IU/mL", "[0.4 - 10] IU/mL", "> 10 IU/mL", to value at D14-31 after end of WHO grade 2 or higher chemotherapy-induced OM classified according to the same three categories.
Measured: From baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start3 May 2021
- Primary completion22 May 2024
- Study completion22 May 2024
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucositis OralStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlène PASQUET, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596410
- Sponsor's protocol ID
- RC31/19/0556
- Acronym
- CURALASE01
- Status last verified
- Nov 2026
- First submitted
- 4 Sep 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Multi-center, Non-inferiority Clinical Trial Comparing Two Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children
- ClinicalTrials.gov ID
- NCT04596410
- Acronym / sponsor ID
- CURALASE01 / RC31/19/0556
- Conditions
- Mucositis Oral
- Keywords
- Children, Oral mucositis, Chemotherapy, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 22 Oct 2020 (actual)
- 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.
Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia.
Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines.
Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLLT applied every other day | Experimental | Radiation: LLLT applied every other dayLow-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day |
| LLLT applied daily | Active comparator | Radiation: LLLT applied dailyLow-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every day |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female children aged ≥ 3 years and < 18 years.
- Hospitalization in an oncology or hematology department in the participating centres.
- Patients with oropharyngeal mucositis of grade 2 or higher (WHO grading system) related to cancer chemotherapy, including conditioning for Hematopoietic Stem Cell Transplantation (HSCT).
- Written informed consent of both patient's holders of parental authority, and patient's assent when applicable.
- Patients affiliated to a French Social Security insurance or equivalent social protection.
Key exclusion criteria (11 listed)
- Patients with a solid cancer lesion in the area of low-level laser application.
- History of cervicofacial radiotherapy.
- Application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization.
- Hyperthyroidism defined by TSH < 0.4 IU/mL at inclusion.
- Patients susceptible to epilepsy seizure.
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 |
|---|---|---|
| LLLT applied every other dayLow-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day | Radiation | LLLT applied every other day |
| LLLT applied dailyLow-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily | Radiation | LLLT applied daily |
Primary outcome
Session evaluation
Time frame: Throught treatment period up to 1 month
Duration (in days) from the day of first PBM session up to the day of first measurement when patient has no longer WHO grade 2 or higher chemotherapy-induced OM related pain at 2 consecutive measurements before the next scheduled PBM session (either active laser application or matching placebo application)
10 secondary outcomes
Production costs evaluation
Time frame: 2 months
Health insurance evaluation
Time frame: 2 months
OM duration evaluation
Time frame: Throught treatment period up to 1 month
OM occurrence
Time frame: 2 months
Feed evaluation
Time frame: 2 months
Analgesic consumption
Time frame: 2 months
PBM evaluation
Time frame: Through treatment period up to 1 month
Pain change evaluation
Time frame: From baseline to each day of PBM session
Adverse events occurrence
Time frame: 2 months
thyroid-stimulating hormone (TSH) evolution
Time frame: From baseline to 2 months
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
Marlène PASQUET principal investigator
University Hospital, Toulouse
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLLT applied every other day and LLLT applied daily in people with Mucositis Oral, run by University Hospital, Toulouse at 16 sites 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
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?
Session evaluation (time frame: Throught treatment period up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.