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Quality of Life in Head and Neck Patients

Quality of Life Assessment Study in Patients With Metastatic Head and Neck Neoplasia Submitted to Immunotherapy in Brazil

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04853862
Acronym
QLiHN
Enrollment
100
Registered
2021-04-21
Start date
2021-05-01
Completion date
2023-06-30
Last updated
2021-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

head and neck, immunotherapy, quality of life

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.

Interventions

OTHERquestionnaire

Questionnaire for health-related quality of life evaluation

Sponsors

University of Brasilia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of life2 yearsEvaluation of quality of life based on validated questionnaire
Overall survival2 yearsOverall survival

Contacts

Primary ContactMarcos Santos, MD PhD
marcosrxt@gmail.com+55 62 992970666
Backup ContactTalita Morais, MSc
talitacavalcanteam@gmail.com+55 61 983554304

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026