RBR-36zcfg The Effects of Auriculotherapy in Women With Breast Cancer During Chemotherapy Treatment

Date of registration: 01/08/2018 ^(mm/dd/yyyy)
Last approval date : 01/08/2018 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1196-7471

• Public title:

  en

  The Effects of Auriculotherapy in Women With Breast Cancer During Chemotherapy Treatment

  pt-br

  Os efeitos da Auriculoterapia em mulheres com Câncer de Mama durante o tratamento de quimioterapia

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 59990016.1.0000.0096
    Issuing authority: plataforma Brasil
  • CEP: 2.098.890
    Issuing authority: Comitê de Ética em Pesquisa do Hospital de Clínicas da Universidade Federal do Paraná

Sponsors

• Primary sponsor: Hospital de Clinicas da Universidade Federal do Paraná
• Secondary sponsor:
  • Institution: Hospital de Clinicas da Universidade Federal do Paraná
• Supporting source:
  • Institution: Hospital de Clinicas da Universidade Federal do Paraná

Health conditions

• Health conditions:

  en

  Women; Breast neoplasms

  pt-br

  Mulheres; Neoplasias de mama

• General descriptors for health conditions:

  en

  C00-D48 II - Neoplasms

  pt-br

  C00-D48 II - Neoplasias [tumores]

• Specific descriptors:

Interventions

• Interventions:

  en

  Intervention group - Application of auriculotherapy in 33 women with breast cancer who are receiving chemotherapy treatment. Crystal beads will be applied to six auricular points Using the dotting pen:: Shenmen, stomach, cardia, kidney, endocrine and brainstem in the bilateral auricle once a week for 12 weeks. A socio-demographic questionnaire will be applied before starting the intervention and the general quality of life questionnaire, QLQ-C30 and QLQ-BR23 specific questionnaire for breast cancer as baseline. The other questionnaires (QLQ-C30 and QLQ-BR23) will be applied at weeks 3, 6, 9 and 12 of crystal bead applications. In the control group, without the intervention of auriculotherapy, 34 women with breast cancer in chemotherapy treatment, only the micropore in the same points, Shenmen, stomach, cardia, kidney, endocrine and brainstem will be applied in the bilateral auricular pavilion, once Per week for 12 weeks. A socio-demographic questionnaire will be applied before starting the micropore application, the QLQ-C30 questionnaire and QLQ-BR23 specific questionnaire for breast cancer as baseline. The other QLQ-C30 and QLQ-BR23 questionnaires will be applied at weeks 3, 6, 9 and 12 of micropore applications.

  pt-br

  Grupo intervenção - Aplicação da auriculoterapia, em 33 mulheres com câncer de mama e que estejam recebendo tratamento quimioterápico. Serão aplicadas esferas de cristal, em seis pontos auriculares, utilizando a caneta localizadora de pontos: Shenmen, estômago, cárdia, rim, endócrino e tronco cerebral, no pavilhão auricular bilateral, 1 vez por semana, durante 12 semanas. Serão aplicados um questionário sócio demográfico antes de iniciar a intervenção e o questionário de qualidade de vida geral,QLQ-C30 e questionário específico QLQ-BR23 para câncer de mama como baseline. Os outros questionários (QLQ-C30 e QLQ-BR23) serão aplicados nas semanas 3, 6, 9 e 12 das aplicações das esferas de cristal. No grupo controle, sem a intervenção da auriculoterapia, serão aplicados em 34 mulheres com câncer de mama em tratamento quimioterápico, apenas o micropore no mesmos pontos, Shenmen, estômago, cárdia, rim, endócrino e tronco cerebral, no pavilhão auricular bilateral, 1 vez por semana, durante 12 semanas. Serão aplicados um questionário sócio demográfico antes de iniciar a aplicação do micropore o questionário de qualidade de vida geral,QLQ-C30 e questionário específico QLQ-BR23 para câncer de mama como baseline. Os outros questionários QLQ-C30 e QLQ-BR23 serão aplicados nas semanas 3, 6, 9 e 12 das aplicações do micropore.

• Descriptors:

  en

  E02.190.044.133 Acupuncture, Ear

  pt-br

  E02.190.044.133 Acupuntura Auricular

  es

  E02.190.044.133 Acupuntura Auricular

  en

  E05.318.308.980 Surveys and Questionnaires

  pt-br

  E05.318.308.980 Inquéritos e Questionários

  es

  E05.318.308.980 Encuestas y Cuestionarios

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 03/15/2017 ^(mm/dd/yyyy)
• Date last enrollment: 01/31/2018 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  67	F	18 Y	99 Y

• Inclusion criteria:

  en

  Women; Diagnosis of breast cancer; Chemotherapy treatment; Age between 18 and 99 years

  pt-br

  Mulheres; diagnóstico de câncer de mama; tratamento quimioterápico; idade entre 18 e 99 anos

• Exclusion criteria:

  en

  Using anxiolytics; Antidepressants; Pregnant women

  pt-br

  Uso de ansiolíticos; antidepressivos; gestantes

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Based on previous studies (CREW et al, 2007), it is expected that 60% of the patients participating in the study will show improvement in cancer-related symptoms and chemotherapy treatment and consequent improvement in Quality of Life measured by the Quality Assessment Questionnaire called EORT-QLQ-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) version 3.0.

  pt-br

  Baseado em estudos anteriores (CREW et al,2007) espera-se que 60% das pacientes que participarão do estudo, apresentem melhora dos sintomas relacionados ao câncer e do tratamento quimioterápico e sua consequente melhora na Qualidade de Vida mensurado pelo questionário de avaliação da Qualidade de Vida denominado EORT- QLQ-30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnarie) versão 3.0.

• Secondary outcomes:

  en

  Based on the same study mentioned above, it is expected an improvement in social well-being of 10%, an improvement of the emotional function of 40% and functional function of 20%, measured by the Quality of Life evaluation questionnaire called EORT-QLQ-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) version 3.0.

  pt-br

  Baseado no mesmo estudo acima citado, espera-se uma melhora no bem estar social de 10%, melhora da função emocional de 40% e da função funcional de 20%, mensurado pelo questionário de avaliação da Qualidade de Vida denominado EORT- QLQ-30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnarie) versão 3.0.

Contacts

• Public contact
  • Full name: Elizabeth Tischenberg Aguiar Vallim
  • • Address: R. Gen. Carneiro, 181 - Alto da Glória
    • City: Curitiba / Brazil
    • Zip code: 80060-900
  • Phone: +55 (41) 3360 1800
  • Email: elizabethvallim@gmail.com
  • Affiliation: Hospital de Clinicas da Universidade Federal do Paraná
   
• Scientific contact
  • Full name: Elizabeth Tischenberg Aguiar Vallim
  • • Address: R. Gen. Carneiro, 181 - Alto da Glória
    • City: Curitiba / Brazil
    • Zip code: 80060-900
  • Phone: +55 (41) 3360 1800
  • Email: elizabethvallim@gmail.com
  • Affiliation: Hospital de Clinicas da Universidade Federal do Paraná
   
• Site contact
  • Full name: Elizabeth Tischenberg Aguiar Vallim
  • • Address: R. Gen. Carneiro, 181 - Alto da Glória
    • City: Curitiba / Brazil
    • Zip code: 80060-900
  • Phone: +55 (41) 3360 1800
  • Email: elizabethvallim@gmail.com
  • Affiliation: Hospital de Clinicas da Universidade Federal do Paraná
  • Full name: Elizabeth Tischenberg Aguiar Vallim
  • • Address: Rua General Carneiro, 181
    • City: Curitiba / Brazil
    • Zip code: 80060-900
  • Phone: 4133601800
  • Email: elizabethvallim@gmail.com
  • Affiliation: Hospital de Clinicas da Universidade Federal do Paraná
   

Additional links:

• Download in ICTRP format