Clinical trial NCT04596410: Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mucositis Oral
Keywords: Children
Oral mucositis
Chemotherapy
Photobiomodulation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 406
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female children aged ≥ 3 years and \< 18 years.
2. Hospitalization in an oncology or hematology department in the participating centres.
3. Patients with oropharyngeal mucositis of grade 2 or higher (WHO grading system) related to cancer chemotherapy, including conditioning for Hematopoietic Stem Cell Transplantation (HSCT).
4. Written informed consent of both patient's holders of parental authority, and patient's assent when applicable.
5. Patients affiliated to a French Social Security insurance or equivalent social protection.
6. Absence of any physical or psychological disability that may interfere with the LLLT application.

Exclusion Criteria:

1. Patients with a solid cancer lesion in the area of low-level laser application.
2. History of cervicofacial radiotherapy.
3. Application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization.
4. Hyperthyroidism defined by TSH \< 0.4 IU/mL at inclusion.
5. Patients susceptible to epilepsy seizure.
6. Patients with pacemaker.
7. 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.
8. Patients protected by law (guardianship and safeguarding of justice).
9. Pregnant female patients as determined by positive serum pregnancy test at screening.
10. Lactating female patients who are actively breast feeding.
11. Participation in another clinical trial involving oral care.

Primary outcomes:
measure: Session evaluation
timeFrame: Throught treatment period up to 1 month
Secondary outcomes:
measure: Production costs evaluation
timeFrame: 2 months
measure: Health insurance evaluation
timeFrame: 2 months
measure: OM duration evaluation
timeFrame: Throught treatment period up to 1 month
measure: OM occurrence
timeFrame: 2 months
measure: Feed evaluation
timeFrame: 2 months
measure: Analgesic consumption
timeFrame: 2 months
measure: PBM evaluation
timeFrame: Through treatment period up to 1 month
measure: Pain change evaluation
timeFrame: From baseline to each day of PBM session
measure: Adverse events occurrence
timeFrame: 2 months
measure: thyroid-stimulating hormone (TSH) evolution
timeFrame: From baseline to 2 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University hospital of Toulouse
state: Occitanie
city: Angers
country: France
facility: University hospital of Angers
city: Besançon
country: France
facility: University hospital of Besançon
city: Grenoble
country: France
facility: University hospital of Grenoble
city: Lille
country: France
facility: University hospital of Lille
city: Limoges
country: France
facility: University hospital of Limoges
city: Marseille
country: France
facility: Hôpital La Timone
city: Nancy
country: France
facility: University hospital of Nancy
city: Nice
country: France
facility: University Hospital of Nice
city: Paris
country: France
facility: Armand Trousseau Hospital
city: Poitiers
country: France
facility: University hospital of Poitiers
city: Reims
country: France
facility: University hospital of Reims
city: Rouen
country: France
facility: University hospital of Rouen
city: Saint-Étienne
country: France
facility: University hospital of Saint-Etienne
city: Strasbourg
country: France
facility: University hospital of Strasbourg
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital, Toulouse
name: Marlène PASQUET
role: PRINCIPAL_INVESTIGATOR
References: