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Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT03983369•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).

Eligibility

Age

4 - 25 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age \> 4 and ≤ 25 years
•2. No mucositis or other mouth lesions at the beginning of chemotherapy that could prevent the laser session and chemotherapy
•3. Cooperative patient, able to wear black glasses and to sit with his open mouth during laser session
•4. Patients treated in one of the SFCE centers that participate to the study
•5. Patients undergoing chemotherapy course with high risk of severe mucositis :
•1. high-dose chemotherapy with hematological stem cell transplantation (stratum A) including but not limited to 8 HDC conditioning regimens for solid tumors intensive treatment (Busilvex-Melphalan, VP16-Thiotepa, BAM, BEAM, Thiotepa 900mg/m\^2, Carboplatine-Thiotepa (typical teratoid rhabdoid tumor or medulloblastoma), VP16-Carboplatine-Thiotepa, Endoxan-Busilvex and VP16 - Melphalan) and 5 myeloablative conditioning regimens (for example : TBI-VP16, Busilvex-Endoxan-Thiotepa, Busilvex-Endoxan+/-Melphalan and Thiotepa-Busulfan-Fludarabine),
•2. Conventional chemotherapy courses (stratum B) but not limited to COPADM (B lymphoma), CAV/ICE (plexus choroid carcinoma or B lymphoma), Head start induction course (medulloblastoma), N6 course (neuroblastoma), VIDE or VCD (Ewing sarcoma), API/AP (osteosarcoma), Cyclophosphamide and Doxorubicine (nephroblastoma), PLADO/Carboplatine and Doxorubicine (hepatoblastoma), IVADo (rhabdomyosarcoma), induction and consolidation of the Myechild protocol (Cytarabine/Mithoxantrone Fludarabine Aractine +/- Darubicine) (acute myeloid leukemia) and 5FU-cisplatine (undifferentiated carcinoma of nasopharyngeal),
•3. Others courses of chemotherapy (stratum A or B) which may cause mucositis can be considered (please refer to the non-inclusion criterion n° 5 to see the prohibited chemotherapy list). In this case, the coordinating investigator approval is required.
•6. Women of childbearing potential must have a negative serum β-HCG pregnancy test prior to the administration of the first laser treatment.
•7. French speaking patients
+3 more criteria

Exclusion Criteria

•1. Treatment by opioids on daily basis
•2. Orthodontic appliance
•3. Pregnant or breastfeeding young ladies or women
•4. Patients with cognitive disorder who could not self-evaluate his pain or with a mucositis difficult to evaluate
•5. None of this chemotherapy is allowed : Methotrexate, VA or VAD (nephroblastoma), Carboplatine - Etoposide (3 or 5 days), Temozolomide single agent or in combination with Topotecan/Irinotecan or Bevacizumab, Gemzar, Taxotere, Ifosfamide - Etoposide (Ewing sarcoma), OEPA, COPDAC, IgEV (Hodgkin lymphoma)

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

Key Dates

Start Date

August 29, 2018

Primary Completion Date

August 28, 2026

Completion Date

September 1, 2026

Last Updated

February 6, 2026

Enrollment

315

ESTIMATED participants

Conditions

Mucositis Oral

Interventions

Low-Level Laser Therapy

DEVICE

Placebo

OTHER

Contacts

Léa Guerrini-Rousseau, MD

CONTACT

+33 (0)1 42 11 67 41 lea.guerrini-rousseau@gustaveroussy.fr

Jérémy MIONE, MS

CONTACT

+33 (0)1 42 11 42 11 jeremy.mione@gustaveroussy.fr

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COMPLETEDPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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