Protocoles de photobiomodulation dans l'analgésie de la mucosite buccale induite par la chimiothérapie chez l'enfant (CURALASE01)
Essai clinique en double aveugle, randomisé, multicentrique et de non-infériorité comparant deux protocoles de photobiomodulation dans l'analgésie de la mucosite buccale induite par la chimiothérapie chez les enfants
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Angers, France
- University hospital of Angers
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Besançon, France
- University hospital of Besançon
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Grenoble, France
- University hospital of Grenoble
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Lille, France
- University hospital of Lille
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Limoges, France
- University hospital of Limoges
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Marseille, France
- Hôpital La Timone
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Nancy, France
- University hospital of Nancy
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Nice, France
- University Hospital of Nice
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Paris, France
- Armand Trousseau Hospital
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Poitiers, France
- University hospital of Poitiers
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Reims, France
- University hospital of Reims
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Rouen, France
- University hospital of Rouen
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Saint-Etienne, France
- University hospital of Saint-Etienne
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Strasbourg, France
- University hospital of Strasbourg
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Tours, France
- University Hospital of Tours
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Occitanie
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Toulouse, Occitanie, France, 31000
- University hospital of Toulouse
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: LLLT applied every other day
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day |
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day |
|
Comparateur actif: LLLT applied daily
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every day |
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Session evaluation
Délai: 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) |
Throught treatment period up to 1 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Production costs evaluation
Délai: 2 months
|
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. |
2 months
|
|
Health insurance evaluation
Délai: 2 months
|
Costs of inpatient hospital stays from the French health insurance perspective. |
2 months
|
|
OM duration evaluation
Délai: Throught treatment period up to 1 month
|
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). |
Throught treatment period up to 1 month
|
|
OM occurrence
Délai: 2 months
|
Occurrence of chemotherapy-induced OM of WHO grade 3 or 4 (deterioration of the clinical situation). |
2 months
|
|
Feed evaluation
Délai: 2 months
|
Occurrence of enteral feeding. |
2 months
|
|
Analgesic consumption
Délai: 2 months
|
Duration (in days) of consumption of step 2 and step 3 analgesics during chemotherapy-induced OM of WHO grade 2 or higher. |
2 months
|
|
PBM evaluation
Délai: Through 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) as evaluated, regardless of patient's age, with the ChIMES scale and use of step 3 analgesics. |
Through treatment period up to 1 month
|
|
Pain change evaluation
Délai: From baseline to each day of PBM session
|
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) |
From baseline to each day of PBM session
|
|
Adverse events occurrence
Délai: 2 months
|
Occurrence of adverse events reported according to descriptions and grading scale found in NCI CTCAE version 5.0. |
2 months
|
|
thyroid-stimulating hormone (TSH) evolution
Délai: From baseline to 2 months
|
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. |
From baseline to 2 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marlène PASQUET, University Hospital, Toulouse
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC31/19/0556
Informations sur les médicaments et les dispositifs, documents d'étude
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