An observational study in Head and Neck Neoplasms, sponsored by Associacao de Investigacao de Cuidados de Suporte em Oncologia. Terminated at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-09.
Sponsored by Associacao de Investigacao de Cuidados de Suporte em Oncologia · Observational
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.
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).
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 21 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Associacao de Investigacao de Cuidados de Suporte em Oncologia is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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)
Time frame: 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)
Time frame: Change of global quality of life score from baseline to 4 months after the treatment is completed
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Change of muscle strength from baseline to the end of treatment
Handgrip maximal isometric muscle strength (long-term)
Measured with manual dynamometers (Kgf).
Time frame: 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).
Time frame: Change of muscle strength from baseline to the end of treatment
Quadriceps maximal isometric muscle strength (long-term)
Measured with manual dynamometers (Kgf).
Time frame: 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
Time frame: Change of repetitions from baseline to the end of treatment
Sit-to-stand test (long-term)
Sit-to-stand test during 30 seconds
Time frame: Change of repetitions from baseline to 4 months after the treatment is completed
Physical function (acute)
6 minutes walking test (meters).
Time frame: Change of distance from baseline to the end of treatment
Physical function (long-term)
6 minutes walking test (meters)
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 2 years follow-up
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Associacao de Investigacao de Cuidados de Suporte em Oncologia