Protocolli di fotobiomodulazione nell'analgesia della mucosite orale indotta da chemioterapia nei bambini (CURALASE01)
Studio clinico in doppio cieco, randomizzato, multicentrico, di non inferiorità che confronta due protocolli di fotobiomodulazione nell'analgesia della mucosite orale indotta da chemioterapia nei bambini
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Angers, Francia
- University hospital of Angers
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Besançon, Francia
- University hospital of Besançon
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Grenoble, Francia
- University hospital of Grenoble
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Lille, Francia
- University hospital of Lille
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Limoges, Francia
- University hospital of Limoges
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Marseille, Francia
- Hôpital La Timone
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Nancy, Francia
- University hospital of Nancy
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Nice, Francia
- University Hospital of Nice
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Paris, Francia
- Armand Trousseau Hospital
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Poitiers, Francia
- University hospital of Poitiers
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Reims, Francia
- University hospital of Reims
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Rouen, Francia
- University hospital of Rouen
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Saint-Etienne, Francia
- University hospital of Saint-Etienne
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Strasbourg, Francia
- University hospital of Strasbourg
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Tours, Francia
- University Hospital of Tours
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Occitanie
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Toulouse, Occitanie, Francia, 31000
- University hospital of Toulouse
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Comparatore attivo: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Session evaluation
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Production costs evaluation
Lasso di tempo: 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
Lasso di tempo: 2 months
|
Costs of inpatient hospital stays from the French health insurance perspective. |
2 months
|
|
OM duration evaluation
Lasso di tempo: 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
Lasso di tempo: 2 months
|
Occurrence of chemotherapy-induced OM of WHO grade 3 or 4 (deterioration of the clinical situation). |
2 months
|
|
Feed evaluation
Lasso di tempo: 2 months
|
Occurrence of enteral feeding. |
2 months
|
|
Analgesic consumption
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Marlène PASQUET, University Hospital, Toulouse
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RC31/19/0556
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