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Recruiting Phase 3 NCT03983369

Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults

Trial Parameters

Condition Mucositis Oral
Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 315
Sex ALL
Min Age 4 Years
Max Age 25 Years
Start Date 2018-08-29
Completion 2026-08-28
Interventions
Low-Level Laser TherapyPlacebo

Brief Summary

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

Inclusion Criteria: 1. Age \> 4 and ≤ 25 years 2. No mucositis or other mouth lesions at the beginning of chemotherapy that could prevent the laser session and chemotherapy 3. Cooperative patient, able to wear black glasses and to sit with his open mouth during laser session 4. Patients treated in one of the SFCE centers that participate to the study 5. Patients undergoing chemotherapy course with high risk of severe mucositis : 1. high-dose chemotherapy with hematological stem cell transplantation (stratum A) including but not limited to 8 HDC conditioning regimens for solid tumors intensive treatment (Busilvex-Melphalan, VP16-Thiotepa, BAM, BEAM, Thiotepa 900mg/m\^2, Carboplatine-Thiotepa (typical teratoid rhabdoid tumor or medulloblastoma), VP16-Carboplatine-Thiotepa, Endoxan-Busilvex and VP16 - Melphalan) and 5 myeloablative conditioning regimens (for example : TBI-VP16, Busilvex-Endoxan-Thiotepa, Busilvex-Endoxan+/-Melphalan and Thiotepa-Busulfan-Fludarabine), 2. Conventional chem

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