Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT (F4T)
31 de julho de 2021 atualizado 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.
Visão geral do estudo
Status
Rescindido
Condições
Descrição detalhada
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 estudo
Observacional
Inscrição (Real)
21
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
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Vila Nova De Gaia, Portugal
- Centro Hospitalar Vila Nova de Gaia / Espinho
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
N/D
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of life (acute)
Prazo: 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)
|
Change of global quality of life score from baseline to the end of treatment
|
|
Quality of life (long-term)
Prazo: Change of global quality of life score from baseline to 4 months after the treatment is completed
|
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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Fatigue (acute)
Prazo: 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)
|
Change of fatigue score from baseline to the end of treatment
|
|
Fatigue (long-term)
Prazo: 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)
|
Change of fatigue score from baseline to 4 months after the treatment is completed
|
|
Social functioning (acute)
Prazo: 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)
|
Change of body mass index from baseline to the end of treatment
|
|
Social functioning (long-term)
Prazo: 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)
Prazo: Change of body mass index from baseline to the end of treatment
|
Body mass index, evaluated by bioelectrical impedance (BMI kg/m^2).
|
Change of body mass index from baseline to the end of treatment
|
|
Body composition (long-term)
Prazo: 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).
|
Change of body mass index from baseline to 4 months after the treatment is completed
|
|
Cognitive function (acute)
Prazo: 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).
|
Change of MoCA score from baseline to the end of treatment
|
|
Cognitive function (long-term)
Prazo: Change of MoCA score from baseline to 4 months after the treatment is completed
|
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)
Prazo: Change of EAT-10 score from baseline to the end of treatment
|
Severity of dysphagia assessed by Eating Assessment Tool (EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of dysphagia)
|
Change of EAT-10 score from baseline to the end of treatment
|
|
Dysphagia (long-term)
Prazo: 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)
|
Change of EAT-10 score from baseline to 4 months after the treatment is completed
|
|
Dysphagia (acute)
Prazo: Change of FOIS score from baseline to the end of treatment
|
Severity of dysphagia assessed by Functional Oral Intake Scale (FOIS ranges from 1 to 7)
|
Change of FOIS score from baseline to the end of treatment
|
|
Dysphagia (long-term)
Prazo: 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)
Prazo: Change of PG-SGA total score from baseline to the end of treatment
|
Evaluated by the Patient-Generated Subjective Global Assessment (PG-SGA range from 0-35 with a higher score reflecting a greater risk of malnutrition).
|
Change of PG-SGA total score from baseline to the end of treatment
|
|
Nutritional status (long-term)
Prazo: 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).
|
Change of PG-SGA total score from baseline to 4 months after the treatment is completed
|
|
Handgrip maximal isometric muscle strength (acute)
Prazo: Change of muscle strength from baseline to the end of treatment
|
Measured with manual dynamometers (Kgf).
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Change of muscle strength from baseline to the end of treatment
|
|
Handgrip maximal isometric muscle strength (long-term)
Prazo: Change of muscle strength from baseline to 4 months after the treatment is completed
|
Measured with manual dynamometers (Kgf).
|
Change of muscle strength from baseline to 4 months after the treatment is completed
|
|
Quadriceps maximal isometric muscle strength (acute)
Prazo: 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)
Prazo: 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)
Prazo: Change of repetitions from baseline to the end of treatment
|
Sit-to-stand test during 30 seconds
|
Change of repetitions from baseline to the end of treatment
|
|
Sit-to-stand test (long-term)
Prazo: Change of repetitions from baseline to 4 months after the treatment is completed
|
Sit-to-stand test during 30 seconds
|
Change of repetitions from baseline to 4 months after the treatment is completed
|
|
Physical function (acute)
Prazo: Change of distance from baseline to the end of treatment
|
6 minutes walking test (meters).
|
Change of distance from baseline to the end of treatment
|
|
Physical function (long-term)
Prazo: 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
|
|
Progression free survival
Prazo: 2 years follow-up
|
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.
|
2 years follow-up
|
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Overall survival
Prazo: 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.
|
2 years follow-up
|
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Capability of tolerating subsequent treatments
Prazo: 2 years follow-up
|
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).
|
2 years follow-up
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Investigador principal: Inês Leão, MD, Centro Hospitalar Vila Nova de Gaia / Espinho
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2019
Conclusão Primária (Real)
3 de março de 2020
Conclusão do estudo (Real)
3 de março de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
25 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de julho de 2021
Primeira postagem (Real)
9 de agosto de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de agosto de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de julho de 2021
Última verificação
1 de julho de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 102/2019
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .