Stents orales impresos en 3D personalizados durante la radioterapia de cabeza y cuello
Un estudio aleatorizado de radioterapia de cabeza y cuello con o sin stents orales impresos en 3D personalizados
This clinical trial studies the effect of customized 3 dimensional (3D) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. Oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. A customized, 3D-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVE:
I. To evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.
SECONDARY OBJECTIVES:
I. To record patient reported outcomes during radiotherapy. II. To evaluate patient narcotic use during radiotherapy. III. To evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3D printed oral stent.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients wear 3D printed oral stent during standard of care radiotherapy.
ARM II: Patients receive standard of care during treatment.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85234
- Banner Health/Banner Research
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-
Florida
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Jacksonville, Florida, Estados Unidos, 32207
- Baptist MD Anderson Cancer Center
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46219
- Community MD Anderson Cancer Center East
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Indianapolis, Indiana, Estados Unidos, 46227
- Community MD Anderson Cancer Center South
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Indianapolis, Indiana, Estados Unidos, 46250
- Community MD Anderson Cancer Center North
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Cooper Hospital University Medical Center
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-
Texas
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Houston, Texas, Estados Unidos, 77030
- M D Anderson Cancer Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy
- Age 18 or older
- ECOG PS 0-2
- The participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s)
- Signed study-specific consent form
Exclusion Criteria:
- Prior head and neck radiotherapy
- Participants is unable to fit a tongue-lateralizing or tongue-depressing stent
- Severe trismus with an incisal opening of <10 mm
- Inability to comply with the study procedures
- Participants younger than 18 years of age
- Participants must not be pregnant
- Cognitively impaired subjects
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm I (3D printed oral stent)
Patients wear 3D printed oral stent during standard of care radiotherapy. |
Receive standard of care
Otros nombres:
Wear 3D printed oral stent |
|
Comparador activo: Arm II (standard of care)
Patients receive standard of care during treatment. |
Receive standard of care
Otros nombres:
Wear 3D printed oral stent |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mucositis toxicity rates
Periodo de tiempo: Through study completion, an average of 1 year
|
Rate of non-target mucose will be estimated along with the corresponding 95% confidence interval. Cochran-Mantel-Haenszel (CHM) test will be applied to compare mucositis rates between the two treatment arms. Logistic regression will be used to compare occurrence of mucositis between two arms, adjusting for the effects of stratification factors as well as other covariates. T test or Wilcoxon rank sum test will be used to compare three Olerud-Molander Ankle Score between two arms: a mean mucositis score, an extent of mucositis score, and a worst site score. |
Through study completion, an average of 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient reported outcomes
Periodo de tiempo: Through study completion, an average of 1 year
|
Will be assessed using the MD Anderson Symptom Inventory Head and Neck questionnaire. T test or Wilcoxon rank sum test will be used to compare scores of each item per time point or sums of scores across all items at each time point or sums across three time point per item between the two arms. Multivariate analyses such as linear regression model adjusting for the effects of covariates might be performed to compare patients reported outcomes. Appropriate data transformation will be performed if necessary for assumption of normality. |
Through study completion, an average of 1 year
|
|
Patients narcotics diaries
Periodo de tiempo: Through study completion, an average of 1 year
|
Will record the worst, the least, the average pain score and pain score at present for each day. Will calculate the average of these 4 scores as a composite daily pain score. |
Through study completion, an average of 1 year
|
|
Imaging difference
Periodo de tiempo: Through study completion, an average of 1 year
|
The set up error during radiation will be measured in each treatment arm. |
Through study completion, an average of 1 year
|
|
Dosimetric difference
Periodo de tiempo: Through study completion, an average of 1 year
|
The radiation dose to healthy tissue will be measured in each treatment arm. |
Through study completion, an average of 1 year
|
|
Composite pain scores
Periodo de tiempo: Through study completion, an average of 1 year
|
An area under curve of pain scores over two weeks (AUC2wks) will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. The linear mixed models will also be fitted to evaluate the association of composite pain scores with occurrence of their non-target mucosa. |
Through study completion, an average of 1 year
|
|
Number of narcotic pills used
Periodo de tiempo: Through study completion, an average of 1 year
|
An AUC2wks will be calculated for each patient, and the t test or Wilcoxon rank sum test will be used to compare the AUC2wks of pain scores between the two arms, and between patients with and without occurrence of mucositis in their non-target mucosa. Will also fit linear mixed models including patients as random effects to compare the composite pain scores over two weeks between treatment arms. |
Through study completion, an average of 1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anna Lee, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Neoplasias de Cabeza y Cuello
- Neoplasias de las vías respiratorias
- Enfermedades de la nariz
- Enfermedades Otorrinolaringológicas
- Enfermedades de las glándulas salivales
- Neoplasias faríngeas
- Neoplasias Otorrinolaringológicas
- Enfermedades faríngeas
- Enfermedades de los senos paranasales
- Enfermedades de la lengua
- Neoplasias de senos paranasales
- Neoplasias de Nariz
- Enfermedades de las parótidas
- Neoplasias de las glándulas salivales
- Neoplasias orofaríngeas
- Neoplasias de la Boca
- Neoplasias de la lengua
- Neoplasias del Seno Maxilar
- Neoplasias de parótida
- Neoplasias Amigdalinas
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Pautas como tema
- Garantía de calidad, atención médica
- Estándar de cuidado
- Directrices de práctica como tema
Otros números de identificación del estudio
- 2020-1153
- NCI-2021-03221 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- 2020-1153 (Otro identificador: M D Anderson Cancer Center)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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