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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Acute and Long-term Impact of Cancer Treatment on Quality-of-life, Physical and Cognitive Function of Head and Neck Cancer Patients

Conditions
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Head and Neck Neoplasms

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Neoplasms, Acute adverse events, Long-term adverse events, Quality of life, Cognitive function, Physical function