Clinical trial NCT04853862: Quality of Life in Head and Neck Patients
Official title: Quality of Life Assessment Study in Patients With Metastatic Head and Neck Neoplasia Submitted to Immunotherapy in Brazil
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Keywords: head and neck
immunotherapy
quality of life
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and neck cancer patients undergoing systemic treatment with immunotherapy

Brief summary: Evaluation of health-related quality of life of head and neck cancer patients undergoing immunotherapy

Detailed description: Introduction: The treatment of head and neck neoplasms, as well as the evolution of the disease, can affect a variety of body functions, including breathing, swallowing and speech, with great potential to cause various physical, emotional, and social problems to the patient, leading to considerable impairment of their quality of life. Several instruments were developed to measure this variable. Such evaluation is currently considered fundamental to report therapeutic results, but there is no consensus regarding the instrument to be employed. The University of Washington questionnaire has been the most widely used so far. EORTC (European Organization for Cancer Research and Treatment) recently published a new questionnaire specifically for patients treated for head and neck cancer (EORTC QLQ-H \& N43), already validated in Portuguese for Brazil.

Objectives: The aim of this prospective and multi-institutional study is to evaluate the quality of life of patients with metastatic head and neck cancer undergoing immunotherapy in different regions of Brazil. Other endpoints will also be evaluated such as disease-free survival and overall survival.

Procedures: EORTC QLQ-30 and EORTC QLQ-H \& N43 questionnaires, validated in Portuguese for Brazil, will be applied to all patients with metastatic head and neck neoplasms undergoing immunotherapy at participating institutions. These will be evaluated before the beginning of the treatment and then every 2 months, for an estimated period of 2 years or until death or on demand, in case of symptomatology that justifies it.

Eligibility criteria: Inclusion Criteria:

Patients with a diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck region, whose planned treatment is immunotherapy, will be included. We will consider, separately, patients that had been treated with platinum before (platinum-refractory) and patients that were not submitted to this treatment (platinum naïve).

Primary site: patients with primary pharyngeal tumors (oro or hypopharynx), oral cavity and larynx will be included.

Exclusion Criteria:

* Patients with cognitive impairment that prevents the proper application of questionnaires
* Brain metastasis
* Autoimmune disease
* Systemic immunosuppressive treatment
* Hepatitis B, C or HIV infection
* Prior immunotherapy

Primary outcomes:
measure: Quality of life
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: