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Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT (F4T)

31 juillet 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Description détaillée

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).

Type d'étude

Observationnel

Inscription (Réel)

21

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Le Portugal
      • Vila Nova De Gaia, Le Portugal
        • Centro Hospitalar Vila Nova de Gaia / Espinho

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

N/A

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Quality of life (acute)
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Fatigue (acute)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Handgrip maximal isometric muscle strength (long-term)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Overall survival
Délai: 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
Capability of tolerating subsequent treatments
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Associacao de Investigacao de Cuidados de Suporte em Oncologia

Collaborateurs

Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
University Institute of Maia

Les enquêteurs

  • Chercheur principal: Inês Leão, MD, Centro Hospitalar Vila Nova de Gaia / Espinho

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2019

Achèvement primaire (Réel)

3 mars 2020

Achèvement de l'étude (Réel)

3 mars 2020

Dates d'inscription aux études

Première soumission

25 avril 2021

Première soumission répondant aux critères de contrôle qualité

31 juillet 2021

Première publication (Réel)

9 août 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 août 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 juillet 2021

Dernière vérification

1 juillet 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 102/2019

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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