Informations générales (source: ClinicalTrials.gov)
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 (MUCILA)
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
août 2018
septembre 2023
29 juin 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:46 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CLCC INSTITUT GUSTAVE ROUSSY | Léa Guerrini-Rousseau, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Oscar Lambret - 59020 - Lille - France | Cyril LERVAT, MD | Contact (sur clinicalTrials) | |||
| CHU de Rennes - 35203 - Rennes - France | Jacinthe Bonneau Lagacherie, MD | Contact (sur clinicalTrials) | |||
| Hôpital Robert Debré - 75019 - Paris - France | Mony FAHD, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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).
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).
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)