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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-25
SponsorGustave Roussy, Cancer Campus, Grand Paris

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

Qualifiers

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

Treatments tested in this trial

  • Low-Level Laser Therapy
  • Placebo

Treatment groups

315 Participants
are divided into 2 treatment groups