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

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: Terminated
• Conditions: Head and Neck Neoplasms

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: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Change of global quality of life score from baseline to 4 months after the treatment is completed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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).	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).	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).	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).	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)	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)	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)	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)	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).	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).	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).	Change of muscle strength from baseline to the end of treatment
Handgrip maximal isometric muscle strength (long-term)	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)	Measured with manual dynamometers (Kgf).	Change of muscle strength from baseline to the end of treatment
Quadriceps maximal isometric muscle strength (long-term)	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)	Sit-to-stand test during 30 seconds	Change of repetitions from baseline to the end of treatment
Sit-to-stand test (long-term)	Sit-to-stand test during 30 seconds	Change of repetitions from baseline to 4 months after the treatment is completed
Physical function (acute)	6 minutes walking test (meters).	Change of distance from baseline to the end of treatment
Physical function (long-term)	6 minutes walking test (meters)	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.	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.	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).	2 years follow-up

Collaborators and Investigators

• Sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Collaborators: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.; University Institute of Maia
• Investigators: Principal Investigator: Inês Leão, MD, Centro Hospitalar Vila Nova de Gaia / Espinho

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Quality of life; Cognitive function; Physical function; Head and Neck Neoplasms; Acute adverse events; Long-term adverse events
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID 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