NCT03983369

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

Multicenter Double Blind Randomized Placebo-controlled Trial Assessing the Efficacy of Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 4 Years – 25 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Mucositis Oral

Interventions

Type	Name	Description
DEVICE	Low-Level Laser Therapy	The 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).
OTHER	Placebo	Placebo

Timeline

• Start date: 2018-08-29
• Primary completion: 2026-08-28
• Completion: 2026-09-01
• First posted: 2019-06-12
• Last updated: 2026-02-06

Locations

5 sites across 1 country: France