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

Gustave Roussy

Status and phase

Enrolling

Phase 3

Conditions

Mucositis Oral

Treatments

Device: Low-Level Laser Therapy

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03983369

2017-A03041-52

2017/2640 (Other Identifier)

Details and patient eligibility

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).

Enrollment

315 estimated patients

Sex

All

Ages

4 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 4 and ≤ 25 years
No mucositis or other mouth lesions at the beginning of chemotherapy that could prevent the laser session and chemotherapy
Cooperative patient, able to wear black glasses and to sit with his open mouth during laser session
Patients treated in one of the SFCE centers that participate to the study
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.
Women of childbearing potential must have a negative serum β-HCG pregnancy test prior to the administration of the first laser treatment.
French speaking patients
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.
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

Treatment by opioids on daily basis
Orthodontic appliance
Pregnant or breastfeeding young ladies or women
Patients with cognitive disorder who could not self-evaluate his pain or with a mucositis difficult to evaluate
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)