RBR-5yjdxvn Profile and associated symptoms of the patient with head and neck cancer

Date of registration: 08/09/2022 ^(mm/dd/yyyy)
Last approval date : 08/09/2022 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-12719697

• Public title:

  en

  Profile and associated symptoms of the patient with head and neck cancer

  pt-br

  Perfil e sintomas associados do paciente com câncer de cabeça e pescoço

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 90563418.6.1001.5417
    Issuing authority: Plataforma Brasil
  • 2.909.482
    Issuing authority: Parecer consubstanciado do Comitê de Ética em Pesquisa da Universidade de São Paulo

Sponsors

• Primary sponsor: Universidade de São Paulo - Campus Bauru
• Secondary sponsor:
  • Institution: Universidade de São Paulo - Campus Bauru
• Supporting source:
  • Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Health conditions

• Health conditions:

  en

  Head and neck neoplasm

  pt-br

  Câncer de cabeça e pescoço

• General descriptors for health conditions:

  en

  C76.8 Malignant neoplasm of other and ill-defined locations with invasive lesion

  pt-br

  C76.8 Neoplasia maligna de outras localizações e das mal definidas com lesão invasiva

• Specific descriptors:

  en

  C760 Head and neck neoplasm

  pt-br

  C760 Câncer de cabeça e pescoço

Interventions

• Interventions:

  en

  We evaluated 30 patients (Total sample was lower than planned due to the closure of the clinical research clinic during the Covid19 pandemic) with head and neck cancer who were treated at the Clinical Research Center of the Faculty of Dentistry of Bauru in a period of 1 year; questionnaires were applied for sociodemographic assessment; xerostomia inventory; impact of oral health on quality of life (ohip-14); cervical disability; and salivary flow test assessments; mouth opening assessment.

  pt-br

  Foram avaliados 30 pacientes (Amostra total foi inferior ao planejado devido ao fechamento da clinica de pesquisa clinica durante a pandemia de Covid19) portadores de câncer de cabeça e pescoço que foram atendidos no Centro de Pesquisa Clínica da Faculdade de Odontologia de Bauru no período de 1 ano; foram aplicados os questionários para avaliação sociodemográfica; inventário de xerostomia; impacto da saúde bucal na qualidade de vida (ohip-14); incapacidade cervical; e as avaliações de teste de fluxo salivar; avaliação de abertura de boca.

• Descriptors:

  en

  D011795 Surveys and Questionnaires

  pt-br

  D011795 inquéritos e questionários

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 04/03/2019 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  30	-	0	0

• Inclusion criteria:

  en

  Patients diagnosed with head and neck cancer; over 18 years of age; in dental treatment at the Faculty of Dentistry of Bauru University of Sao Paulo Clinical Research Center; who agreed to participate in the study and signed the informed consent form

  pt-br

  Pacientes com diagnóstico de câncer de cabeça e pescoço; maiores de 18 anos de idade; em tratamento odontológico no Centro de Pesquisa clínica da Faculdade de Odontologia de Bauru Universidade de São Paulo; que concordem em participar do estudo assinando o Termo de consentimento livre e esclarecido

• Exclusion criteria:

  en

  Individuals who did not accept to participate in the research or who had neurological disorders and or cognitive deficits

  pt-br

  Indivíduos que não aceitem participar da pesquisa ou que apresentem alterações neurológicas e ou déficit cognitivo

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  Expected outcome Complaint of Xerostomia or low salivary flow or hyposalivation in at least evaluated by the stimulated and non-stimulated sialometry exam; pain in the oral cavity; worsening of quality of life assessed by the Oral Health Impact Profile questionnaire; patients with lower socioeconomic conditions had more mouth complaints

  pt-br

  Desfecho esperado Queixa de Xerostomia ou baixo fluxo salivar ou hipossalivação avaliada pelo exame de sialometria estimulada e não estimulada; dor em cavidade oral; piora na qualidade de vida avaliada pelo questionário Oral Health Impact Profile; pacientes com condições sócio econômicas mais baixas apresentaram mais queixa em boca

• Secondary outcomes:

  en

  Endpoint found Complaint of Xerostomia or low salivary flow or hyposalivation was diagnosed; oral cavity pain; there was an average impact on the worsening of the quality of life of the research participants

  pt-br

  Desfecho encontrado Queixa de Xerostomia ou baixo fluxo salivar ou hipossalivação; dor em cavidade oral; houve um impacto médio na piora na qualidade de vida dos participantes da pesquisa

Contacts

• Public contact
  • Full name: Paulo Sérgio da Silva Santos
  • • Address: Alameda Otavio Pinheiro Brizola n 9-75
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55(14)32358000
  • Email: paulosergiosilvasantos@gmail.com
  • Affiliation: Universidade de São Paulo - Campus Bauru
   
• Scientific contact
  • Full name: Paulo Sérgio da Silva Santos
  • • Address: Alameda Otavio Pinheiro Brizola n 9-75
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55(14)32358000
  • Email: paulosergiosilvasantos@gmail.com
  • Affiliation: Universidade de São Paulo - Campus Bauru
   
• Site contact
  • Full name: Paulo Sérgio da Silva Santos
  • • Address: Alameda Otavio Pinheiro Brizola n 9-75
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55(14)32358000
  • Email: paulosergiosilvasantos@gmail.com
  • Affiliation: Universidade de São Paulo - Campus Bauru
  • Full name: Paulo Sérgio da Silva Santos
  • • Address: Alameda Otavio Pinheiro Brisolla, n° 9-75
    • City: Bauru / Brazil
    • Zip code: 17012-901
  • Phone: +55-14-32266113
  • Email: paulosergiosilvasantos@gmail.com
  • Affiliation: Universidade de São Paulo - Campus Bauru
   

Additional links:

• Download in ICTRP format