Clinical trial NCT04996147: Acute and Long-term Impact of Cancer Treatment on Head and Neck Cancer Patients: FIT4TREATMENT
Official title: Acute and Long-term Impact of Cancer Treatment on Quality-of-life, Physical and Cognitive Function of Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Neoplasms
Keywords: Head and Neck Neoplasms
Acute adverse events
Long-term adverse events
Quality of life
Cognitive function
Physical function
Lead sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
name: University Institute of Maia
First posted: 2021-08-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life (acute)
timeFrame: Change of global quality of life score from baseline to the end of treatment
measure: Quality of life (long-term)
timeFrame: Change of global quality of life score from baseline to 4 months after the treatment is completed
Secondary outcomes:
measure: Fatigue (acute)
timeFrame: Change of fatigue score from baseline to the end of treatment
measure: Fatigue (long-term)
timeFrame: Change of fatigue score from baseline to 4 months after the treatment is completed
measure: Social functioning (acute)
timeFrame: Change of body mass index from baseline to the end of treatment
measure: Social functioning (long-term)
timeFrame: Change of body mass index from baseline to 4 months after the treatment is completed
measure: Body composition (acute)
timeFrame: Change of body mass index from baseline to the end of treatment
measure: Body composition (long-term)
timeFrame: Change of body mass index from baseline to 4 months after the treatment is completed
measure: Cognitive function (acute)
timeFrame: Change of MoCA score from baseline to the end of treatment
measure: Cognitive function (long-term)
timeFrame: Change of MoCA score from baseline to 4 months after the treatment is completed
measure: Dysphagia (acute)
timeFrame: Change of EAT-10 score from baseline to the end of treatment
measure: Dysphagia (long-term)
timeFrame: Change of EAT-10 score from baseline to 4 months after the treatment is completed
measure: Dysphagia (acute)
timeFrame: Change of FOIS score from baseline to the end of treatment
measure: Dysphagia (long-term)
timeFrame: Change of FOIS score from baseline to 4 months after the treatment is completed
measure: Nutritional status (acute)
timeFrame: Change of PG-SGA total score from baseline to the end of treatment
measure: Nutritional status (long-term)
timeFrame: Change of PG-SGA total score from baseline to 4 months after the treatment is completed
measure: Handgrip maximal isometric muscle strength (acute)
timeFrame: Change of muscle strength from baseline to the end of treatment
measure: Handgrip maximal isometric muscle strength (long-term)
timeFrame: Change of muscle strength from baseline to 4 months after the treatment is completed
measure: Quadriceps maximal isometric muscle strength (acute)
timeFrame: Change of muscle strength from baseline to the end of treatment
measure: Quadriceps maximal isometric muscle strength (long-term)
timeFrame: Change of muscle strength score from baseline to 4 months after the treatment is completed
measure: Sit-to-stand test (acute)
timeFrame: Change of repetitions from baseline to the end of treatment
measure: Sit-to-stand test (long-term)
timeFrame: Change of repetitions from baseline to 4 months after the treatment is completed
measure: Physical function (acute)
timeFrame: Change of distance from baseline to the end of treatment
measure: Physical function (long-term)
timeFrame: Change of distance from baseline to 4 months after the treatment is completed
measure: Progression free survival
timeFrame: 2 years follow-up
measure: Overall survival
timeFrame: 2 years follow-up
measure: Capability of tolerating subsequent treatments
timeFrame: 2 years follow-up
Other outcomes:
Locations:
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia / Espinho
Study officials:
affiliation: Centro Hospitalar Vila Nova de Gaia / Espinho
name: Inês Leão, MD
role: PRINCIPAL_INVESTIGATOR
References: