Actively Recruiting

Phase 3
Age: 4Years - 25Years
All Genders
NCT03983369

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

Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2026-02-06

315

Participants Needed

5

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 4Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 4 and less than or equal to 25 years
  • No mucositis or other mouth lesions at the start of chemotherapy that could prevent laser treatment and chemotherapy
  • Able and cooperative to wear black glasses and keep mouth open during laser therapy sessions
  • Treated at one of the SFCE centers participating in the study
  • Undergoing chemotherapy with a high risk of severe mucositis, including specific high-dose or conventional chemotherapy regimens
  • Women of childbearing potential must have a negative serum beta-HCG pregnancy test before first laser treatment
  • French speaking patients
  • Patient and/or parents/legal representatives must understand and sign informed consent and be willing to comply with study visits and procedures
  • Patients must be affiliated with a social security system or be beneficiaries
  • Patients without cancer but undergoing high-risk chemotherapy for other reasons are eligible
Not Eligible

You will not qualify if you...

  • Receiving daily opioid treatment
  • Wearing an orthodontic appliance
  • Pregnant or breastfeeding women
  • Cognitive disorders preventing self-evaluation of pain or mucositis assessment
  • Receiving prohibited chemotherapy drugs such as Methotrexate, VA or VAD, Carboplatine-Etoposide, Temozolomide, Gemzar, Taxotere, Ifosfamide-Etoposide, OEPA, COPDAC, or IgEV

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Gustave Roussy

Villejuif, Val de Marne, France, 94805

Actively Recruiting

2

Centre Oscar Lambret

Lille, France, 59020

Actively Recruiting

3

Hôpital Robert Debré

Paris, France, 75019

Actively Recruiting

4

Institut Curie

Paris, France, 75248

Actively Recruiting

5

CHU de Rennes

Rennes, France, 35203

Actively Recruiting

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Research Team

L

Léa Guerrini-Rousseau, MD

CONTACT

J

Jérémy MIONE, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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