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RECRUITING
NCT03983369
PHASE3

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

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

4 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

315

Start Date

2018-08-29

Completion Date

2026-09

Last Updated

2026-02-06

Healthy Volunteers

No

Conditions

Interventions

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

Locations (5)

Gustave Roussy

Villejuif, Val de Marne, France

Centre Oscar Lambret

Lille, France

Hôpital Robert Debré

Paris, France

Institut Curie

Paris, France

CHU de Rennes

Rennes, France