Actively Recruiting
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
Eligibility Criteria
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
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
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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