Head and Neck NeoplasmsF4TNCT04996147
Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT
An observational study of Head and Neck Neoplasms, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- How many people
- 21 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2019to 3 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Synchronous tumors or other comorbidities with associated uncontrolled symptoms.
- Inability to provide informed consent.
- Expected inability to fulfil the propose schedule and follow-up.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar Vila Nova de Gaia / Espinho
Vila Nova de Gaia
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and Neck Neoplasms, Acute adverse events, Long-term adverse events, Quality of life, Cognitive function, Physical function
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (acute)
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)
Measured: Change of global quality of life score from baseline to the end of treatment
Quality of life (long-term)
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)
Measured: Change of global quality of life score from baseline to 4 months after the treatment is completed
Secondary outcomes (25)
Fatigue (acute)
Fatigue score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents high level of symptomatology / problems)
Measured: Change of fatigue score from baseline to the end of treatment
Fatigue (long-term)
Fatigue score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents high level of symptomatology / problems)
Measured: Change of fatigue score from baseline to 4 months after the treatment is completed
Social functioning (acute)
Social functioning score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
Measured: Change of body mass index from baseline to the end of treatment
Social functioning (long-term)
Social functioning score evaluated by EORTC QLQ-C30 questionnaire (range in score from 0 to 100, high score represents a high level of functioning)
Measured: Change of body mass index from baseline to 4 months after the treatment is completed
Body composition (acute)
Body mass index, evaluated by bioelectrical impedance (BMI kg/m^2).
Measured: Change of body mass index from baseline to the end of treatment
Body composition (long-term)
Body mass index, evaluated by bioelectrical impedance (BMI kg/m^2).
Measured: Change of body mass index from baseline to 4 months after the treatment is completed
Cognitive function (acute)
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).
Measured: Change of MoCA score from baseline to the end of treatment
Cognitive function (long-term)
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).
Measured: Change of MoCA score from baseline to 4 months after the treatment is completed
Dysphagia (acute)
Severity of dysphagia assessed by Eating Assessment Tool (EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of dysphagia)
Measured: Change of EAT-10 score from baseline to the end of treatment
Dysphagia (long-term)
Severity of dysphagia assessed by Eating Assessment Tool (EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of dysphagia)
Measured: Change of EAT-10 score from baseline to 4 months after the treatment is completed
Dysphagia (acute)
Severity of dysphagia assessed by Functional Oral Intake Scale (FOIS ranges from 1 to 7)
Measured: Change of FOIS score from baseline to the end of treatment
Dysphagia (long-term)
Severity of dysphagia assessed by Functional Oral Intake Scale (FOIS ranges from 1 to 7)
Measured: Change of FOIS score from baseline to 4 months after the treatment is completed
Nutritional status (acute)
Evaluated by the Patient-Generated Subjective Global Assessment (PG-SGA range from 0-35 with a higher score reflecting a greater risk of malnutrition).
Measured: Change of PG-SGA total score from baseline to the end of treatment
Nutritional status (long-term)
Evaluated by the Patient-Generated Subjective Global Assessment (PG-SGA range from 0-35 with a higher score reflecting a greater risk of malnutrition).
Measured: Change of PG-SGA total score from baseline to 4 months after the treatment is completed
Handgrip maximal isometric muscle strength (acute)
Measured with manual dynamometers (Kgf).
Measured: Change of muscle strength from baseline to the end of treatment
Handgrip maximal isometric muscle strength (long-term)
Measured with manual dynamometers (Kgf).
Measured: Change of muscle strength from baseline to 4 months after the treatment is completed
Quadriceps maximal isometric muscle strength (acute)
Measured with manual dynamometers (Kgf).
Measured: Change of muscle strength from baseline to the end of treatment
Quadriceps maximal isometric muscle strength (long-term)
Measured with manual dynamometers (Kgf).
Measured: Change of muscle strength score from baseline to 4 months after the treatment is completed
Sit-to-stand test (acute)
Sit-to-stand test during 30 seconds
Measured: Change of repetitions from baseline to the end of treatment
Sit-to-stand test (long-term)
Sit-to-stand test during 30 seconds
Measured: Change of repetitions from baseline to 4 months after the treatment is completed
Physical function (acute)
6 minutes walking test (meters).
Measured: Change of distance from baseline to the end of treatment
Physical function (long-term)
6 minutes walking test (meters)
Measured: Change of distance from baseline to 4 months after the treatment is completed
Progression free survival
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.
Measured: 2 years follow-up
Overall survival
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.
Measured: 2 years follow-up
Capability of tolerating subsequent treatments
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).
Measured: 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Jun 2019
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., University Institute of Maia
- Responsible party
- Sponsor
- Investigators
- Inês Leão, MD, Principal investigator, Centro Hospitalar Vila Nova de Gaia / Espinho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996147
- Sponsor's protocol ID
- 102/2019
- Acronym
- F4T
- Status last verified
- Jul 2021
- First submitted
- 25 Apr 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Long-term Impact of Cancer Treatment on Quality-of-life, Physical and Cognitive Function of Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT04996147
- Acronym / sponsor ID
- F4T / 102/2019
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and Neck Neoplasms, Acute adverse events, Long-term adverse events, Quality of life, Cognitive function, Physical function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Associacao de Investigacao de Cuidados de Suporte em OncologiaUniversity, hospital or other
- Collaborators
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., University Institute of Maia
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Synchronous tumors or other comorbidities with associated uncontrolled symptoms.
- Inability to provide informed consent.
- Expected inability to fulfil the propose schedule and follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life (acute)
Time frame: 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)
Quality of life (long-term)
Time frame: 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)
25 secondary outcomes
Fatigue (acute)
Time frame: Change of fatigue score from baseline to the end of treatment
Fatigue (long-term)
Time frame: Change of fatigue score from baseline to 4 months after the treatment is completed
Social functioning (acute)
Time frame: Change of body mass index from baseline to the end of treatment
Social functioning (long-term)
Time frame: Change of body mass index from baseline to 4 months after the treatment is completed
Body composition (acute)
Time frame: Change of body mass index from baseline to the end of treatment
Body composition (long-term)
Time frame: Change of body mass index from baseline to 4 months after the treatment is completed
Cognitive function (acute)
Time frame: Change of MoCA score from baseline to the end of treatment
Cognitive function (long-term)
Time frame: Change of MoCA score from baseline to 4 months after the treatment is completed
Dysphagia (acute)
Time frame: Change of EAT-10 score from baseline to the end of treatment
Dysphagia (long-term)
Time frame: Change of EAT-10 score from baseline to 4 months after the treatment is completed
Dysphagia (acute)
Time frame: Change of FOIS score from baseline to the end of treatment
Dysphagia (long-term)
Time frame: Change of FOIS score from baseline to 4 months after the treatment is completed
Nutritional status (acute)
Time frame: Change of PG-SGA total score from baseline to the end of treatment
Nutritional status (long-term)
Time frame: Change of PG-SGA total score from baseline to 4 months after the treatment is completed
Handgrip maximal isometric muscle strength (acute)
Time frame: Change of muscle strength from baseline to the end of treatment
Handgrip maximal isometric muscle strength (long-term)
Time frame: Change of muscle strength from baseline to 4 months after the treatment is completed
Quadriceps maximal isometric muscle strength (acute)
Time frame: Change of muscle strength from baseline to the end of treatment
Quadriceps maximal isometric muscle strength (long-term)
Time frame: Change of muscle strength score from baseline to 4 months after the treatment is completed
Sit-to-stand test (acute)
Time frame: Change of repetitions from baseline to the end of treatment
Sit-to-stand test (long-term)
Time frame: Change of repetitions from baseline to 4 months after the treatment is completed
Physical function (acute)
Time frame: Change of distance from baseline to the end of treatment
Physical function (long-term)
Time frame: Change of distance from baseline to 4 months after the treatment is completed
Progression free survival
Time frame: 2 years follow-up
Overall survival
Time frame: 2 years follow-up
Capability of tolerating subsequent treatments
Time frame: 2 years follow-up
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inês Leão, MD principal investigator
Centro Hospitalar Vila Nova de Gaia / Espinho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms, run by Associacao de Investigacao de Cuidados de Suporte em Oncologia at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (acute) (time frame: Change of global quality of life score from baseline to the end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.