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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Mucositis Oral
• Intervention / Treatment: Other: Placebo; Device: Low-Level Laser Therapy

• Study Type: Interventional
• Enrollment (Estimated): 315
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Léa Guerrini-Rousseau, MD; Phone Number: +33 (0)1 42 11 67 41; Email: lea.guerrini-rousseau@gustaveroussy.fr
• Study Contact Backup: Name: Jérémy MIONE, MS; Phone Number: 38 61 +33 (0)1 42 11 42 11; Email: jeremy.mione@gustaveroussy.fr

Study Locations

• France
  • Lille, France, 59020
    • Recruiting
    • Centre Oscar Lambret
    • Contact: Cyril LERVAT, MD
  • Paris, France, 75019
    • Recruiting
    • Hôpital Robert Debré
    • Contact: Mony FAHD, MD
  • Paris, France, 75248
    • Recruiting
    • Institut Curie
    • Contact: Camille CORDERO, MD
  • Rennes, France, 35203
    • Recruiting
    • CHU de Rennes
    • Contact: Jacinthe Bonneau Lagacherie, MD
  • Val de Marne
    • Villejuif, Val de Marne, France, 94805
      • Recruiting
      • Gustave Roussy
      • Contact: Léa Guerrini-Rousseau, MD; Phone Number: +33 (0)1 42 11 67 41; Email: lea.guerrini-rousseau@gustaveroussy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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
8. Patient and/or parents/legal representatives should understand, sign, and date the written informed consent form prior to any protocol specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
9. Patients must be affiliated to a social security regimen or beneficiary of the same

NB : all patients who respect all the eligibility criteria are recruitable even if the patient haven't a cancer (Patients undergoing a chemotherapy with high risk of severe mucositis for another clinical reason than cancer).

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preventive treatment with LLLT ("Laser" group)	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).
Placebo Comparator: control group with a placebo intervention	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of grade 3-4 mucositis	assessed at day 12 ± 2 days after initiation of chemotherapy

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatitis; Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: 2017-A03041-52; 2017/2640 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No