RBR-47yx6p9 Use of Ginger to control nausea and vomiting caused by chemotherapy in patients with cervical cancer undergoing treatmen...

Date of registration: 12/16/2021 ^(mm/dd/yyyy)
Last approval date : 12/16/2021 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code:

• Public title:

  en

  Use of Ginger to control nausea and vomiting caused by chemotherapy in patients with cervical cancer undergoing treatment: an experiment

  pt-br

  Uso do Gengibre no controle de enjoos e vômitos provocados por quimioterapia em pacientes com Câncer de colo de útero em tratamento: um experimento

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 40602320.0.0000.5293
    Issuing authority: Plataforma Brasil
  • 4.522.594
    Issuing authority: Parecer emitido pelo comitê de ética da Liga Norte Riograndense Contra o Câncer

Sponsors

• Primary sponsor: Liga Norte Riograndense Contra o Câncer
• Secondary sponsor:
  • Institution: Liga Norte Riograndense Contra o Câncer
• Supporting source:
  • Institution: Liga Norte Riograndense Contra o Câncer

Health conditions

• Health conditions:

  en

  Vomiting; Nausea.

  pt-br

  Vômito; Náusea

• General descriptors for health conditions:

  en

  C06.405.748 Stomach Diseases

  pt-br

  C06.405.748 Gastropatias

• Specific descriptors:

  en

  C23.888.821.712 Nausea

  pt-br

  C23.888.821.712 Náusea

  en

  C23.888.821.937 Vomiting

  pt-br

  C23.888.821.937 Vômito

Interventions

• Interventions:

  en

  Experimental Group 1 (EG1): 16 women given cervical cancer treatment with Cisplatin associated with radiotherapy will receive capsules containing 250mg of the ginger extract contained in capsules, ingested with approximately 250 ml of water every 12 hours, totaling 500mg per day. Experimental Group 2 (EG2): 16 women given cervical cancer treatment with Cisplatin associated with radiotherapy will receive capsules containing 500mg of the ginger extract contained in capsules, ingested with approximately 250 ml of water every 12 hours, totaling 1g per day. Control Group (CG): 16 women with cervical cancer treatment with Cisplatin associated with radiotherapy will use capsules containing 500mg of placebo contained in capsules, ingested with approximately 250ml of water every 12 hours, totaling 1g per day.

  pt-br

  Grupo Experimental 1 (GE1): 16 mulheres diagnosticadas com neoplasia de colo uterino submetidas a tratamento com Cisplatina associada a radioterapia receberão cápsulas contendo 250mg de extrato de gengibre contido em cápsulas, ingerido com aproximadamente 250 ml de água a cada 12 horas totalizando 500mg por dia. Grupo Experimental 2 (GE2): 16 mulheres diagnosticadas com neoplasia de colo uterino submetidas a tratamento com Cisplatina associada a radioterapia receberão cápsulas contendo 500mg de extrato de gengibre contido em cápsulas, ingerido com aproximadamente 250 ml de água a cada 12 horas totalizando 1g por dia. Grupo Controle (GC): 16 mulheres diagnosticadas com neoplasia de colo uterino submetidas a tratamento com Cisplatina associada a radioterapia farão uso de cápsulas contendo 500mg de placebo contido em cápsulas , ingerido com aproximadamente 250ml de água a cada 12 horas totalizando 1g por dia.

• Descriptors:

  en

  B01.650.940.800.575.912.250.618.937.900. Ginger

  pt-br

  B01.650.940.800.575.912.250.618.937.900. Gengibre

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 03/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  48	F	18 Y	0

• Inclusion criteria:

  en

  Over 18 years old; have a diagnosis of cervical cancer with histological confirmation; have an indication for treatment with cisplatin 40mg/m² weekly associated with radiotherapy; preserved capsule swallowing capacity

  pt-br

  Superior a 18 anos; ter diagnóstico de neoplasia em colo uterino com comprovação histológica; ter indicação de tratamento com cisplatina 40mg/m² semanal associada a radioterapia; capacidade preservada de deglutição de cápsulas.

• Exclusion criteria:

  en

  Have a history of hypersensitivity to ginger; pregnancy or breastfeeding; have another primary neoplasm; ongoing chemotherapy treatment; having undergone previous antineoplastic and/or radiotherapy treatment; radiotherapy treatment in the epigastric region of the abdomen; surgery scheduled during the study period; have any feeding device (nasoenteric tube, gastrostomy, or jejunostomy); in simultaneous use of a supplement or ginger-based foods; using anticoagulants; have a history of bleeding disorders (severe thrombocytopenia), hyperthyroidism, and heart disease; a pre-existing condition causing nausea and vomiting.

  pt-br

  Ter histórico de hipersensibilidade ao gengibre; gravidez ou em aleitamento materno; possuir outra neoplasia primária; tratamento quimioterápico prévio; ter realizado tratamento antineoplásico e/ou radioterápico prévio; tratamento radioterápico em região epigástrica do abdome; cirurgia programada durante o período do estudo; possuir algum dispositivo alimentar (sonda nasoentérica, gastrostomia ou jejunostomia); em uso simultâneo de suplemento ou alimentos à base de gengibre; em uso de anticoagulantes; ter histórico de distúrbios hemorrágicos (trombocitopenia grave), hipertireoidismo e cardiopatia; pré-existência de afecção causadora de náuseas e vômitos.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Factorial	3	Triple-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Assess the reduction of nausea and vomiting using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 scale adapted for nausea and vomiting. In this way, it is possible to measure the intensity and intensity of events.

  pt-br

  Avaliar a redução das náuseas e vômitos mediante escala Common Terminology Criteria for Adverse Events (CTCAE) Versão 5.0 adaptada para náuseas e vômitos. Desta forma, é possível mensurar a gravidade e intensidade desses eventos.

• Secondary outcomes:

  en

  To assess the quality of life of patients using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) and EORTC quality of life cervical cancer module (EORTC QLQ Cx24). With these instruments it is expected to analyze the interference of the treatment in the quality of life, as well as the influence of ginger in its improvement.

  pt-br

  Avaliar a qualidade de vida das pacientes por meio das medidas European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) e EORTC quality of life cervical cancer module (EORTC QLQ Cx24). Com estes instrumentos espera-se analisar a interferência do tratamento na qualidade de vida, bem como a influência do gengibre em sua melhora.

Contacts

• Public contact
  • Full name: Romeika Lorena Mendes da Silva
  • • Address: Rua Equador, 17, Lagoa Nova
    • City: Natal / Brazil
    • Zip code: 59063310
  • Phone: +55-084-999616690
  • Email: lorena.romeika@gmail.com
  • Affiliation:
   
• Scientific contact
  • Full name: Rodrigo Assis Neves Dantas
  • • Address: Campos Univertsitário, Br-101, s/n - Lagoa Nova
    • City: Natal / Brazil
    • Zip code: 59072970
  • Phone: +55-084-32153615
  • Email: rodrigoenf@yahoo.com.br
  • Affiliation:
   
• Site contact
  • Full name: Renata Lima Pessoa
  • • Address: Av. Miguel Castro, 1355, Nossa Senhora de Nazaré
    • City: Natal / Brazil
    • Zip code: 59062000
  • Phone: +55-084-40095595
  • Email: renata.pessoa@liga.org.br
  • Affiliation:
   

Additional links:

• Download in ICTRP format