RBR-2ryhcv Evaluation of blood microcirculation by cheek laser Doppler flowmetry in patients undergoing chemotherapy or…

Date of registration: 01/29/2020 ^(mm/dd/yyyy)
Last approval date : 01/29/2020 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: u1111-1243-8397

• Public title:

  en

  Evaluation of blood microcirculation by cheek laser Doppler flowmetry in patients undergoing chemotherapy or radiotherapy

  pt-br

  Avaliação da microcirculação sanguínea através da Fluxometria Laser Doppler na região de bochecha em pacientes sob quimioterapia ou radioterapia

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 41935515.6.0000.5417
    Issuing authority: Plataforma Brasil
  • 990.656
    Issuing authority: Comitê de Ética em Pesquisa da Faculdade de Odontologia de Bauru da Universidade de São Paulo

Sponsors

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

Health conditions

• Health conditions:

  en

  Head and Neck Neoplasms; Stomatitis; Antineoplastic Combined Chemotherapy Protocols

  pt-br

  Neoplasias de Cabeça e Pescoço; Estomatite; Protocolos de Quimioterapia Combinada Antineoplásica

• General descriptors for health conditions:

  en

  C00-D48 II - Neoplasms

  pt-br

  C00-D48 II - Neoplasias [tumores]

• Specific descriptors:

Interventions

• Interventions:

  en

  506/5000 Patient assessments prior to initiation of antineoplastic therapy and during the intensive phase of head and neck radiotherapy or chemotherapy, at 7-point chemotherapy (11 patients) and 8-point radiotherapy (3 patientes). For this evaluation, the Laser Doppler Flowmeter was used to record blood flow; the WHO (World Health Organization) and OMAS (Oral Mucositis Assessment Scale) scales for the evaluation of the degree of mucositis; and Visual Analog Scale (VAS) for the evaluation of oral mucosa pain.

  pt-br

  Avaliações dos pacientes antes do início da terapia antineoplásica e durante a fase intensiva da radioterapia de cabeça e pescoço ou quimioterapia, em 7 momentos na quimioterapia (11 pacientes) e 8 momentos na radioterapia (3 pacientes). Para esta avaliação foi utilizado o Fluxômetro Laser Doppler para o registro do fluxo sanguíneo; as escalas da OMS (Organização Mundial da Saúde) e OMAS (Oral Mucositis Assessment Scale) para a avaliação do grau de mucosite; e Escala Visual Analógica (EVA) para a avaliação da dor em mucosa oral.

• Descriptors:

  en

  G09.330.100.780 Regional Blood Flow

  pt-br

  G09.330.100.780 Fluxo Sanguíneo Regional

  es

  G09.330.100.780 Flujo Sanguíneo Regional

  en

  C76.0 Malignant neoplasm of head, face and neck

  pt-br

  C76.0 Neoplasia maligna da cabeça, face e pescoço

  es

  C76.0 Tumor maligno de la cabeza, cara y cuello

  en

  C76.8 Overlapping lesion of other and ill-defined sites

  pt-br

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

  es

  C76.8 Lesión de sitios contiguos mal definidos

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 06/08/2015 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  14	-	18 Y	100 -

• Inclusion criteria:

  en

  Diagnosis of malignant tumor; Therapeutic regimen associated with high risk of developing oral mucositis. Standard chemotherapy and or head and neck radiotherapy; Over age 18 years.

  pt-br

  Diagnóstico de tumor maligno; Regime terapêutico associado a alto risco de desenvolvimento de mucosite oral. Quimioterapia padrão e ou radioterapia de cabeça e pescoço; Idade superior a 18 anos.

• Exclusion criteria:

  en

  Pregnancy; Diabetic; Smoker Patients with uncontrolled blood pressure

  pt-br

  Gravidez; Diabético; Fumante; Pacientes com pressão arterial não controlada

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Other	N/A	0	N/A	N/A	N/A

Outcomes

• Primary outcomes:

  en

  Alteration of blood microcirculation in the genial region during chemotherapy and radiotherapy determined by laser doppler flowmetry at baseline and at end of study   oral mucositis (WHO and OMAS) and AVS.

  pt-br

  Alteração da microcirculação sanguínea na região geniana durante a quimioterapia e radioterapia determinada através da fluxometria laser doppler no início do estudo e no fim do estudo, mucosite oral (OMS e OMAS) e EVA.

• Secondary outcomes:

  en

  Alteration in the blood microcirculation of the genian region, increase of the degree of oral mucositis and increase of value of the AVS scale.

  pt-br

  Alteração na microcirculação sanguínea da região geniana, aumento do grau de mucosite oral e aumento de valor da escala EVA.

Contacts

• Public contact
  • 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
   
• Scientific contact
  • 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
   
• Site contact
  • 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