Evaluation of Cognitive Function of Patients With Sunitinib or Sorafenib
Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib
Patients with advanced kidney cancer or GIST (Gastro Intestinal Stromal Tumor: this is a tumor of the intestines) may be eligible for treatment with one of the following drugs: sunitinib (Sutent ®) or sorafenib (Nexavar ®). These drugs inhibit blood vessel formation in cancer cells. These cancer cells are hampered in their growth. To enlarge the investigators knowledge on the effects and side effects of these two medicines, in the University Medical Center St. Radboud lot of research is done. This study is a part of that.
Patients receiving sunitinib or sorafenib tell sometimes that they feel that they are less able to concentrate, that their memory is not working properly or that they are less able to imagine a solution to a complex problem . Perhaps you recognize these symptoms as well. In how many of the patients this occurs, how severe the symptoms are and how it is caused, is still unknown.
The goal of this research is to examine how memory, concentration and knowledge processing works in patients using sorafenib or sunitinib. With the research the investigators hope to get answers to the following questions:
- How common are problems with memory, concentration and processing of knowledge in patients receiving the drug sunitinib or sorafenib?
- What are the problems of memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
- What could be the cause of the problems that patients experience from memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
- Is there a link between problems with memory, concentration and processing of knowledge and also experiences of fatigue or mood of a patient?
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Gelderland
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Nijmegen, Gelderland, Holanda, 6500 HB
- University Medical Centre Nijmegen
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients:
- patients with metastatic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for ≥ 8 weeks
- Karnofsky score > 70%
- age > 18 year.
- written informed consent for study
Patient controls selection
- patients with metastatic renal cell cancer or GIST who aren't treated yet (only interferon alfa or interleukine 2 treatment is allowed when > 12 months ago.
- Karnofsky score > 70%
- age > 18 year.
- written informed consent for study
Exclusion Criteria:
- Patients:
- contra-indications for treatment with Sunitinib or Sorafenib
- patients who do not speak or write the Dutch language adequately
- known brain metastasis
- use of psychiatric or anti-epileptic medication
- known cognitive disorders unrelated to diagnosis or medication use
- radiotherapy on the brain at any time in the past
- systemic chemotherapy
- in the last 12 months interferon alfa or interleukin-2 treatment
- operation in the last 3 months
- Stroke/TIA (transient ischaemic attack)
Patient controls section:
- patients who do not speak or write the Dutch language adequately
- known brain metastasis
- use of psychiatric or anti-epileptic medication
- known cognitive disorders unrelated to diagnosis or medication use
- radiotherapy on the brain at any time in the past
- systemic chemotherapy
- in the last 12 months interferon alfa or interleukin-2 treatment
- operation in the last 3 months
- stroke/TIA (transient ischaemic attack)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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metastatic Renal Cell Carcinoma without treatment
patients with metastasized RCC who did not receive treatment
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mRCC with treatment
patients with metastastic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for ≥ 8 weeks |
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UMCNONCO200904
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