Phase
Condition
Mucositis
Treatment
Placebo
Low-Level Laser Therapy
Clinical Study ID
Ages 4-25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age > 4 and ≤ 25 years
No mucositis or other mouth lesions at the beginning of chemotherapy that couldprevent the laser session and chemotherapy
Cooperative patient, able to wear black glasses and to sit with his open mouthduring 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 :
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),
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),
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.
Women of childbearing potential must have a negative serum β-HCG pregnancy testprior to the administration of the first laser treatment.
French speaking patients
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.
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:
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 amucositis 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 combinationwith Topotecan/Irinotecan or Bevacizumab, Gemzar, Taxotere, Ifosfamide - Etoposide (Ewing sarcoma), OEPA, COPDAC, IgEV (Hodgkin lymphoma)
Study Design
Connect with a study center
Gustave Roussy
Villejuif, Val De Marne 94805
FranceActive - Recruiting
Centre Oscar Lambret
Lille, 59020
FranceActive - Recruiting
Hôpital Robert Debré
Paris, 75019
FranceActive - Recruiting
Institut Curie
Paris, 75248
FranceActive - Recruiting
CHU de Rennes
Rennes, 35203
FranceActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.