About this trial
To assess the efficacy of preventive Low-Level Laser Therapy (LLLT) for reducing the incidence of WHO's grade 3-4 oral mucositis in children and young adults receiving chemotherapy regimens associated with a high rate of mucositis: conventional chemotherapy or High Dose Chemotherapy (HDC) conditioning regimens with Hematological Stem Cell Transplantation (HSCT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 4 and ≤ 25 years
No mucositis or other mouth lesions at the beginning of chemotherapy that could prevent the laser session and chemotherapy
Cooperative patient, able to wear black glasses and to sit with his open mouth during laser session
Patients treated in one of the SFCE centers that participate to the study
Disqualifiers
Treatment by opioids on daily basis
Orthodontic appliance
Pregnant or breastfeeding young ladies or women
Patients with cognitive disorder who could not self-evaluate his pain or with a mucositis difficult to evaluate
Trial design
Parallel
Treatments tested in this trial
Low-Level Laser Therapy
DeviceThe LLL used is the K-Laser Cube 3. The LLL is an athermal laser beam of low power, equipped with a placebo function (dummy imitating beam laser light, emitted by the same device but without physiological effect).
Placebo
Other interventionPlacebo
Treatment groups
Trial outcomes
Primary outcomes
Proportion of grade 3-4 mucositis
Sponsors and contacts
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