Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT (F4T)
2021. július 31. frissítette: 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.
A tanulmány áttekintése
Állapot
Megszűnt
Körülmények
Részletes leírás
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).
Tanulmány típusa
Megfigyelő
Beiratkozás (Tényleges)
21
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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-
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Vila Nova De Gaia, Portugália
- Centro Hospitalar Vila Nova de Gaia / Espinho
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
N/A
Tanulmányozható nemek
Összes
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
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.
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Quality of life (acute)
Időkeret: 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)
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Fatigue (acute)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
|
|
Dysphagia (long-term)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Nyomozók
- Kutatásvezető: Inês Leão, MD, Centro Hospitalar Vila Nova de Gaia / Espinho
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2019. június 1.
Elsődleges befejezés (Tényleges)
2020. március 3.
A tanulmány befejezése (Tényleges)
2020. március 3.
Tanulmányi regisztráció dátumai
Először benyújtva
2021. április 25.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2021. július 31.
Első közzététel (Tényleges)
2021. augusztus 9.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2021. augusztus 9.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2021. július 31.
Utolsó ellenőrzés
2021. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 102/2019
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
NEM
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