Phase
Condition
Mucositis
Treatment
LLLT applied daily
LLLT applied every other day
Clinical Study ID
Ages 3-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 CellTransplantation (HSCT).
- Written informed consent of both patient's holders of parental authority, andpatient's assent when applicable.
- Patients affiliated to a French Social Security insurance or equivalent socialprotection.
- Absence of any physical or psychological disability that may interfere with the LLLTapplication.
Exclusion
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 torandomization.
- 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 asolid 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.
Study Design
Connect with a study center
University hospital of Toulouse
Toulouse, Occitanie 31000
FranceActive - Recruiting
University hospital of Angers
Angers,
FranceActive - Recruiting
University hospital of Besançon
Besançon,
FranceActive - Recruiting
University hospital of Grenoble
Grenoble,
FranceActive - Recruiting
University hospital of Lille
Lille,
FranceActive - Recruiting
University hospital of Limoges
Limoges,
FranceActive - Recruiting
Hôpital La Timone
Marseille,
FranceActive - Recruiting
University hospital of Nancy
Nancy,
FranceActive - Recruiting
University Hospital of Nice
Nice,
FranceActive - Recruiting
Armand Trousseau Hospital
Paris,
FranceActive - Recruiting
University hospital of Poitiers
Poitiers,
FranceActive - Recruiting
University hospital of Reims
Reims,
FranceActive - Recruiting
University hospital of Rouen
Rouen,
FranceActive - Recruiting
University hospital of Saint-Etienne
Saint-Étienne,
FranceActive - Recruiting
University hospital of Strasbourg
Strasbourg,
FranceActive - Recruiting
University Hospital of Tours
Tours,
FranceActive - Recruiting
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