Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT (F4T)
31 de julio de 2021 actualizado por: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Acute and Long-term Impact of Cancer Treatment on Quality-of-life, Physical and Cognitive Function of Head and Neck Cancer Patients
Head and Neck Squamous Cell Carcinoma (HNSCC) is the 6th most common cancer.
Most cases are diagnosed in locally advanced stages, with treatment involving multimodal approach with combinations of radiotherapy, surgery and chemotherapy.
The aggressive nature of HNSCCs and treatment modalities are associated with important acute and late toxicities that often promote temporary or definitive treatment interruption and may compromised the capability to tolerate subsequent treatments.
Thus, the aim of this study is to analyze the acute and long-term impact of cancer treatment on quality of life, physical and cognitive function of HNSCC patients diagnosed with a locally advanced disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Potential cases will be identified at the multidisciplinary head and neck group meeting.
If the case meets eligibility an informed consent will be presented to the patient.
Interested participants will be scheduled for baseline assessment before the beginning of treatment (M0).
At the end of CRT patients will be submitted to a second assessment (M1).
Follow-up assessments will occur 16th to 18th weeks after the treatment is completed (M2).
Patients proposed to surgery or induction chemotherapy will also be submitted to an additional assessment before the beginning of CRT (Mc / Mic).
Tipo de estudio
De observación
Inscripción (Actual)
21
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Vila Nova De Gaia, Portugal
- Centro Hospitalar Vila Nova de Gaia / Espinho
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Eligible patients had to have more than 18 years, diagnosed with stage III to IVB HNSCC and proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone.
Exclusion criteria was: 1) synchronous tumors or other comorbidities with associated uncontrolled symptoms; 2) inability to provide informed consent; 3) expected inability to fulfil the propose schedule and follow-up.
Descripción
Inclusion Criteria:
- Patients older than 18 years.
- Diagnosis of locally advanced head and neck cancer (oral cavity, oropharynx, hypopharynx, larynx), stage III-IVB.
- Proposed for primary treatment with curative intent - surgery or induction chemotherapy before chemoradiotherapy (CRT) or CRT alone.
Exclusion Criteria:
- Synchronous tumors or other comorbidities with associated uncontrolled symptoms.
- Inability to provide informed consent.
- Expected inability to fulfil the propose schedule and follow-up.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of life (acute)
Periodo de tiempo: Change of global quality of life score from baseline to the end of treatment
|
Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
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Change of global quality of life score from baseline to the end of treatment
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Quality of life (long-term)
Periodo de tiempo: Change of global quality of life score from baseline to 4 months after the treatment is completed
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Global quality of life score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
|
Change of global quality of life score from baseline to 4 months after the treatment is completed
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fatigue (acute)
Periodo de tiempo: Change of fatigue score from baseline to the end of treatment
|
Fatigue score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents high level of symptomatology / problems)
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Change of fatigue score from baseline to the end of treatment
|
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Fatigue (long-term)
Periodo de tiempo: Change of fatigue score from baseline to 4 months after the treatment is completed
|
Fatigue score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents high level of symptomatology / problems)
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Change of fatigue score from baseline to 4 months after the treatment is completed
|
|
Social functioning (acute)
Periodo de tiempo: Change of body mass index from baseline to the end of treatment
|
Social functioning score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
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Change of body mass index from baseline to the end of treatment
|
|
Social functioning (long-term)
Periodo de tiempo: Change of body mass index from baseline to 4 months after the treatment is completed
|
Social functioning score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
|
Change of body mass index from baseline to 4 months after the treatment is completed
|
|
Body composition (acute)
Periodo de tiempo: Change of body mass index from baseline to the end of treatment
|
Body mass index, evaluated by bioelectrical impedance (BMI kg/m^2).
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Change of body mass index from baseline to the end of treatment
|
|
Body composition (long-term)
Periodo de tiempo: Change of body mass index from baseline to 4 months after the treatment is completed
|
Body mass index, evaluated by bioelectrical impedance (BMI kg/m^2).
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Change of body mass index from baseline to 4 months after the treatment is completed
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|
Cognitive function (acute)
Periodo de tiempo: Change of MoCA score from baseline to the end of treatment
|
Evaluated by the Montreal Cognitive Assessment and the Functional Assessment of Cancer Therapy-Cognitive (MoCA score range between 0 and 30, a score of 26 or over is considered to be normal).
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Change of MoCA score from baseline to the end of treatment
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Cognitive function (long-term)
Periodo de tiempo: Change of MoCA score from baseline to 4 months after the treatment is completed
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Evaluated by the Montreal Cognitive Assessment and the Functional Assessment of Cancer Therapy-Cognitive (MoCA score range between 0 and 30, a score of 26 or over is considered to be normal).
|
Change of MoCA score from baseline to 4 months after the treatment is completed
|
|
Dysphagia (acute)
Periodo de tiempo: Change of EAT-10 score from baseline to the end of treatment
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Severity of dysphagia assessed by Eating Assessment Tool (EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of dysphagia)
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Change of EAT-10 score from baseline to the end of treatment
|
|
Dysphagia (long-term)
Periodo de tiempo: Change of EAT-10 score from baseline to 4 months after the treatment is completed
|
Severity of dysphagia assessed by Eating Assessment Tool (EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of dysphagia)
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Change of EAT-10 score from baseline to 4 months after the treatment is completed
|
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Dysphagia (acute)
Periodo de tiempo: Change of FOIS score from baseline to the end of treatment
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Severity of dysphagia assessed by Functional Oral Intake Scale (FOIS ranges from 1 to 7)
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Change of FOIS score from baseline to the end of treatment
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Dysphagia (long-term)
Periodo de tiempo: Change of FOIS score from baseline to 4 months after the treatment is completed
|
Severity of dysphagia assessed by Functional Oral Intake Scale (FOIS ranges from 1 to 7)
|
Change of FOIS score from baseline to 4 months after the treatment is completed
|
|
Nutritional status (acute)
Periodo de tiempo: Change of PG-SGA total score from baseline to the end of treatment
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Evaluated by the Patient-Generated Subjective Global Assessment (PG-SGA range from 0-35 with a higher score reflecting a greater risk of malnutrition).
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Change of PG-SGA total score from baseline to the end of treatment
|
|
Nutritional status (long-term)
Periodo de tiempo: Change of PG-SGA total score from baseline to 4 months after the treatment is completed
|
Evaluated by the Patient-Generated Subjective Global Assessment (PG-SGA range from 0-35 with a higher score reflecting a greater risk of malnutrition).
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Change of PG-SGA total score from baseline to 4 months after the treatment is completed
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Handgrip maximal isometric muscle strength (acute)
Periodo de tiempo: Change of muscle strength from baseline to the end of treatment
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Measured with manual dynamometers (Kgf).
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Change of muscle strength from baseline to the end of treatment
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Handgrip maximal isometric muscle strength (long-term)
Periodo de tiempo: Change of muscle strength from baseline to 4 months after the treatment is completed
|
Measured with manual dynamometers (Kgf).
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Change of muscle strength from baseline to 4 months after the treatment is completed
|
|
Quadriceps maximal isometric muscle strength (acute)
Periodo de tiempo: Change of muscle strength from baseline to the end of treatment
|
Measured with manual dynamometers (Kgf).
|
Change of muscle strength from baseline to the end of treatment
|
|
Quadriceps maximal isometric muscle strength (long-term)
Periodo de tiempo: Change of muscle strength score from baseline to 4 months after the treatment is completed
|
Measured with manual dynamometers (Kgf).
|
Change of muscle strength score from baseline to 4 months after the treatment is completed
|
|
Sit-to-stand test (acute)
Periodo de tiempo: Change of repetitions from baseline to the end of treatment
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Sit-to-stand test during 30 seconds
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Change of repetitions from baseline to the end of treatment
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Sit-to-stand test (long-term)
Periodo de tiempo: Change of repetitions from baseline to 4 months after the treatment is completed
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Sit-to-stand test during 30 seconds
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Change of repetitions from baseline to 4 months after the treatment is completed
|
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Physical function (acute)
Periodo de tiempo: Change of distance from baseline to the end of treatment
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6 minutes walking test (meters).
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Change of distance from baseline to the end of treatment
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Physical function (long-term)
Periodo de tiempo: Change of distance from baseline to 4 months after the treatment is completed
|
6 minutes walking test (meters)
|
Change of distance from baseline to 4 months after the treatment is completed
|
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Progression free survival
Periodo de tiempo: 2 years follow-up
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Defined as the time from the beginning of treatment to the date of first progression or death (whichever occurs first) and will be censored at last follow-up date if the patient does not have the event.
A progression (local, regional or distant) will be assumed accordingly to the imaging evaluation and/or histopathologic confirmation.
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2 years follow-up
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Overall survival
Periodo de tiempo: 2 years follow-up
|
Defined as the time from the beginning of treatment to the date of death from any cause, for patients who do not die, it will be censored at their last follow-up date.
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2 years follow-up
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Capability of tolerating subsequent treatments
Periodo de tiempo: 2 years follow-up
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Defined as the proportion of patients that complete the first cycle of the first line palliative chemotherapy after a documented progression (considering all patients with a formal indication).
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2 years follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Inês Leão, MD, Centro Hospitalar Vila Nova de Gaia / Espinho
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2019
Finalización primaria (Actual)
3 de marzo de 2020
Finalización del estudio (Actual)
3 de marzo de 2020
Fechas de registro del estudio
Enviado por primera vez
25 de abril de 2021
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2021
Publicado por primera vez (Actual)
9 de agosto de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
9 de agosto de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2021
Última verificación
1 de julio de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 102/2019
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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