Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children
NCT ID: NCT04596410
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
406 participants
INTERVENTIONAL
2021-05-03
2024-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LLLT applied every other day
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day
LLLT applied every other day
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day
LLLT applied daily
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every day
LLLT applied daily
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily
Interventions
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LLLT applied every other day
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day
LLLT applied daily
Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily
Eligibility Criteria
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Inclusion Criteria
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
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.
3 Years
17 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Marlène PASQUET
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital of Nice
Nice, , France
Armand Trousseau Hospital
Paris, , France
University hospital of Poitiers
Poitiers, , France
University hospital of Reims
Reims, , France
University hospital of Rouen
Rouen, , France
University hospital of Toulouse
Toulouse, Occitanie, France
University hospital of Angers
Angers, , France
University hospital of Besançon
Besançon, , France
University hospital of Grenoble
Grenoble, , France
University hospital of Lille
Lille, , France
University hospital of Limoges
Limoges, , France
Hôpital La Timone
Marseille, , France
University hospital of Nancy
Nancy, , France
University hospital of Saint-Etienne
Saint-Etienne, , France
University hospital of Strasbourg
Strasbourg, , France
University Hospital of Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Isabelle PELLIER, MD
Role: primary
Sebastien KLEIN, MD
Role: primary
Dominique PLANTAZ, MD
Role: primary
Wadih ABOU CHAHLA, MD
Role: primary
Caroline OUDOT, MD
Role: primary
Arthur STERIN, MD
Role: primary
Julie VALDUGA, MD
Role: primary
Marilyne POIREE, MD
Role: primary
Catherine DOLLFUS, MD
Role: primary
Chrystelle DUPRAZ, MD
Role: primary
Claire PLUCHART, MD
Role: primary
Marie, MD
Role: primary
Sandrine THOUVENIN -DOULET, MD
Role: primary
Catherine PAILLARD, MD
Role: primary
Julien, MD
Role: primary
Other Identifiers
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RC31/19/0556
Identifier Type: -
Identifier Source: org_study_id
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