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

Last updated: May 6, 2025
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Overall Status: Active - Recruiting

Phase

3

Condition

Mucositis

Treatment

Placebo

Low-Level Laser Therapy

Clinical Study ID

NCT03983369
2017-A03041-52
2017/2640
  • Ages 4-25
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age > 4 and ≤ 25 years

  2. No mucositis or other mouth lesions at the beginning of chemotherapy that couldprevent the laser session and chemotherapy

  3. Cooperative patient, able to wear black glasses and to sit with his open mouthduring 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 :

  6. high-dose chemotherapy with hematological stem cell transplantation (stratum A)including but not limited to 8 HDC conditioning regimens for solid tumorsintensive treatment (Busilvex-Melphalan, VP16-Thiotepa, BAM, BEAM, Thiotepa 900mg/m^2, Carboplatine-Thiotepa (typical teratoid rhabdoid tumor ormedulloblastoma), VP16-Carboplatine-Thiotepa, Endoxan-Busilvex and VP16 -Melphalan) and 5 myeloablative conditioning regimens (for example : TBI-VP16,Busilvex-Endoxan-Thiotepa, Busilvex-Endoxan+/-Melphalan andThiotepa-Busulfan-Fludarabine),

  7. Conventional chemotherapy courses (stratum B) but not limited to COPADM (Blymphoma), CAV/ICE (plexus choroid carcinoma or B lymphoma), Head startinduction 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 myeloidleukemia) and 5FU-cisplatine (undifferentiated carcinoma of nasopharyngeal),

  8. Others courses of chemotherapy (stratum A or B) which may cause mucositis canbe considered (please refer to the non-inclusion criterion n° 5 to see theprohibited chemotherapy list). In this case, the coordinating investigatorapproval is required.

  9. Women of childbearing potential must have a negative serum β-HCG pregnancy testprior to the administration of the first laser treatment.

  10. French speaking patients

  11. Patient and/or parents/legal representatives should understand, sign, and date thewritten informed consent form prior to any protocol specific procedures performed.Patient should be able and willing to comply with study visits and procedures as perprotocol.

  12. 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

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 amucositis 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 combinationwith Topotecan/Irinotecan or Bevacizumab, Gemzar, Taxotere, Ifosfamide - Etoposide (Ewing sarcoma), OEPA, COPDAC, IgEV (Hodgkin lymphoma)

Study Design

Total Participants: 315
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 29, 2018
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Gustave Roussy

    Villejuif, Val De Marne 94805
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille, 59020
    France

    Active - Recruiting

  • Hôpital Robert Debré

    Paris, 75019
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75248
    France

    Active - Recruiting

  • CHU de Rennes

    Rennes, 35203
    France

    Active - Recruiting

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