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临床试验/NCT04853862
NCT04853862Unknown不适用

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

University of Brasilia0 个研究点目标入组 100 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Overall survival

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Overall survival

时间窗: 2 years

Overall survival

Quality of life

时间窗: 2 years

Evaluation of quality of life based on validated questionnaire

次要结局

未报告次要终点

研究者

发起方
University of Brasilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcos Santos

MD PhD

University of Brasilia

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