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

February 5, 2026 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
315

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lille, France, 59020
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
          • Cyril LERVAT, MD
      • Paris, France, 75019
        • Recruiting
        • Hopital Robert Debre
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of grade 3-4 mucositis
Time Frame: assessed at day 12 ± 2 days after initiation of chemotherapy
assessed at day 12 ± 2 days after initiation of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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