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

Head and Neck Neoplasms Clinical Trial

— F4T  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04996147
• Other study ID #: 102/2019
• Status: Terminated
• Start date: June 1, 2019
• Est. completion date: March 3, 2020

Study information

• Verified date: July 2021
• Source: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Vila Nova de Gaia / Espinho	Vila Nova De Gaia

Sponsors (3)

Lead Sponsor	Collaborator
Associacao de Investigacao de Cuidados de Suporte em Oncologia	Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., University Institute of Maia

Country where clinical trial is conducted

Portugal, 

Outcome

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