MUCIPLIQA Randomized Controlled Study Evaluating the Effect of MUCIPLIQ Versus Placebo on the Incidence of Radio-chemotherapy-induced Mucositis in Patients Suffering of Upper Aerodigestive Tract Carcinomas
Placebo
+ MUCIPLIQ
+ MUCIPLIQ
Enfermedades Estomatognáticas
+ Enfermedades de la boca
+ Estomatitis
Estudio de Prevención
Resumen
Fecha de inicio: 1 de marzo de 2013
Fecha en la que se inscribió al primer participante.MUCIPLIQ is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are involved 1) in the stabilization of cells micro-environment, known as extracellular matrix, by binding to structural proteins, and 2) in cells communication process by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, MUCIPLIQ provides a protection, and restores the matrix scaffold and cells communication, a process known as Matrix Therapy. The purpose of this new controlled study is to determine whether MUCIPLIQ can decrease the incidence and the severity of radio-chemotherapy-induced mucositis in patients suffering of upper aerodigestive tract cancers, when used as a preventive agent. The study's main hypothesis is that MUCIPLIQ mouthwash applications before radiotherapy would protect the healthy oral tissue against cytotoxic effect of chemotherapy and radiations.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 136 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Patient suffering from an upper aerodigestive tract carcinoma treated by radiotherapy alone or radiotherapy associated with a concomitant platine-salts-based chemotherapy ; Patient suffering of an upper aerodigestive tract carcinoma without entrance or located in the oral cavity, in the oropharynx or in the rhinopharynx ; Patient age of 18 years old or higher ; Writing informed consent to participate to the trial ; Patient affiliated to the French social security system. Exclusion Criteria: Treatment by non-standard fragmentation (concentrate irradiation) Carcinoma located in the hypopharynx or in the larynx ; Known hypersensitivity to heparinoids ; Patient who already benefited from a radiotherapy treatment ; Patient who already benefited from a chemotherapy treatment. Patients who benefited from neoadjuvant chemotherapy as part of their upper aerodigestive tract carcinoma care, may be included if it was held at least 4 weeks before the inclusion visit ; Patient participating to another biomedical research ; Pregnant woman, breastfeeding woman, parturient or likely to be ; Patient deprived of freedom, under supervision or guardianship ; Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
33.333333333333336% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
PlaceboGrupo II
ExperimentalGrupo III
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 5 ubicaciones
Centre de Cancérologie Léon Bérard
Lyon, FranceAbrir Centre de Cancérologie Léon Bérard en Google MapsCHRU de Besançon, Site du CH Belfort-Montbéliard
Montbéliard, FranceCentre Hospitalier Intercommunal de Créteil
Créteil, FranceAPHP - Hôpital Tenon
Paris, France