Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT (F4T)
31 juli 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Gedetailleerde beschrijving
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).
Studietype
Observationeel
Inschrijving (Werkelijk)
21
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Vila Nova De Gaia, Portugal
- Centro Hospitalar Vila Nova de Gaia / Espinho
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
NVT
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Quality of life (acute)
Tijdsspanne: Change of global quality of life score from baseline to the end of treatment
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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)
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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)
Tijdsspanne: 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)
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Change of global quality of life score from baseline to 4 months after the treatment is completed
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Fatigue (acute)
Tijdsspanne: 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)
Tijdsspanne: Change of fatigue score from baseline to 4 months after the treatment is completed
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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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
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|
Body composition (long-term)
Tijdsspanne: 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
|
|
Cognitive function (acute)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
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Change of EAT-10 score from baseline to the end of treatment
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|
Dysphagia (long-term)
Tijdsspanne: 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
|
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Dysphagia (acute)
Tijdsspanne: 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)
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Change of FOIS score from baseline to the end of treatment
|
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Dysphagia (long-term)
Tijdsspanne: 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)
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Change of FOIS score from baseline to 4 months after the treatment is completed
|
|
Nutritional status (acute)
Tijdsspanne: 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
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Nutritional status (long-term)
Tijdsspanne: Change of PG-SGA total score from baseline to 4 months after the treatment is completed
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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).
|
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)
Tijdsspanne: 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)
Tijdsspanne: 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
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Quadriceps maximal isometric muscle strength (acute)
Tijdsspanne: 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)
Tijdsspanne: 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
|
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Sit-to-stand test (acute)
Tijdsspanne: Change of repetitions from baseline to the end of treatment
|
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)
Tijdsspanne: 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)
Tijdsspanne: Change of distance from baseline to the end of treatment
|
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)
Tijdsspanne: Change of distance from baseline to 4 months after the treatment is completed
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6 minutes walking test (meters)
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Change of distance from baseline to 4 months after the treatment is completed
|
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Progression free survival
Tijdsspanne: 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.
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2 years follow-up
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Overall survival
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Inês Leão, MD, Centro Hospitalar Vila Nova de Gaia / Espinho
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2019
Primaire voltooiing (Werkelijk)
3 maart 2020
Studie voltooiing (Werkelijk)
3 maart 2020
Studieregistratiedata
Eerst ingediend
25 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
31 juli 2021
Eerst geplaatst (Werkelijk)
9 augustus 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 augustus 2021
Laatste update ingediend die voldeed aan QC-criteria
31 juli 2021
Laatst geverifieerd
1 juli 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 102/2019
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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