Head and Neck Neoplasms
Conditions
Keywords
Head and Neck Neoplasms, Acute adverse events, Long-term adverse events, Quality of life, Cognitive function, Physical function
Brief 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. 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).
Interventions
None listed
Sponsors
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
University Institute of Maia
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (acute) | 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social functioning (acute) | 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) |
| Social functioning (long-term) | 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) |
| Body composition (acute) | Change of body mass index from baseline to the end of treatment | Body mass index, evaluated by bioelectrical impedance (BMI kg/m\^2). |
| Body composition (long-term) | 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). |
| Cognitive function (acute) | 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). |
| Cognitive function (long-term) | 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). |
| Dysphagia (acute) | 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) |
| Dysphagia (long-term) | 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) |
| Nutritional status (acute) | 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). |
| Nutritional status (long-term) | 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). |
| Fatigue (acute) | 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) |
| Handgrip maximal isometric muscle strength (long-term) | Change of muscle strength from baseline to 4 months after the treatment is completed | Measured with manual dynamometers (Kgf). |
| Quadriceps maximal isometric muscle strength (acute) | Change of muscle strength from baseline to the end of treatment | Measured with manual dynamometers (Kgf). |
| Quadriceps maximal isometric muscle strength (long-term) | Change of muscle strength score from baseline to 4 months after the treatment is completed | Measured with manual dynamometers (Kgf). |
| Sit-to-stand test (acute) | Change of repetitions from baseline to the end of treatment | Sit-to-stand test during 30 seconds |
| Sit-to-stand test (long-term) | Change of repetitions from baseline to 4 months after the treatment is completed | Sit-to-stand test during 30 seconds |
| Physical function (acute) | Change of distance from baseline to the end of treatment | 6 minutes walking test (meters). |
| Physical function (long-term) | Change of distance from baseline to 4 months after the treatment is completed | 6 minutes walking test (meters) |
| Progression free survival | 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. |
| Overall survival | 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. |
| Capability of tolerating subsequent treatments | 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). |
| Handgrip maximal isometric muscle strength (acute) | Change of muscle strength from baseline to the end of treatment | Measured with manual dynamometers (Kgf). |
| Fatigue (long-term) | 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) |
Countries
Portugal
Outcome results
None listed