Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04853862
Study type Observational
Source University of Brasilia
Contact Marcos Santos, MD PhD
Phone +55 62 992970666
Email [email protected]
Status Not yet recruiting
Phase
Start date May 1, 2021
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03997643 - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial Phase 2
Recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04700475 - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients. N/A
Withdrawn NCT04058145 - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02572869 - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03651570 - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study N/A
Recruiting NCT03843554 - Commensal Oral Microbiota in H&N Cancer N/A
Active, not recruiting NCT02823574 - Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Phase 2
Not yet recruiting NCT04877860 - Pain Treatment in Oncology Population. PaiNEd Study. N/A
Withdrawn NCT03238638 - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy Phase 2
Active, not recruiting NCT03688646 - Efficacy of ONS Supplementation in HNC Outpatient Under Treatment N/A
Completed NCT03302676 - The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors N/A
Recruiting NCT02546895 - Prospective Registration of Head and Neck Cancer
Active, not recruiting NCT02308072 - Phase I Study of Olaparib Combined With Cisplatin-based Chemoradiotherapy to Treat Locally Advanced Head and Neck Cancer Phase 1
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Completed NCT02554968 - Reliability and Validity of Patient Reported Outcome Measures in Head and Neck Cancer
Recruiting NCT02489084 - Predictive Models for Radiation-induced Side Effects in Head and Neck Cancer Based on Single Nucleotide Polymorphisms (SNP)
Completed NCT01952821 - Validity and Reliability of Outcome Measures in Patients With Cancer of the Head and Neck N/A