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

July 31, 2021 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change of global quality of life score from baseline to the end of treatment
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)
Change of global quality of life score from baseline to 4 months after the treatment is completed

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fatigue (acute)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Associacao de Investigacao de Cuidados de Suporte em Oncologia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
University Institute of Maia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Inês Leão, MD, Centro Hospitalar Vila Nova de Gaia / Espinho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 3, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 102/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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