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Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib


N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Renal Cell Cancer, GIST

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Trial Information

Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib


In this study we will focus on subjective and objective cognitive dysfunctioning in patients
with metastatic cancer, treated with sunitinib or sorafenib. In our own clinical practice a
substantial part of our patients that are treated with targeted therapies directed against
VEGF, mention that they have problems with concentrating and that their memory function is
decreased. Relatives sometimes point out that the behaviour of the patient is slightly
different than before starting the VEGF (Vascular Endothelial Growth Factor) inhibition.
Pre-clinical studies show that VEGF influences growth and recovery of neurons.


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)

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

C.M.L. van Herpen, Md PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Nijmegen

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

UMCNONCO200904

NCT ID:

NCT01246843

Start Date:

July 2009

Completion Date:

April 2011

Related Keywords:

  • Metastatic Renal Cell Cancer
  • GIST
  • sunitinib
  • sorafenib
  • cognitive functioning
  • Carcinoma, Renal Cell

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