Evaluation of Cognitive Function of Patients With Sunitinib or Sorafenib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01246843
First received: November 22, 2010
Last updated: November 1, 2011
Last verified: October 2011
  Purpose

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:

  1. How common are problems with memory, concentration and processing of knowledge in patients receiving the drug sunitinib or sorafenib?
  2. What are the problems of memory, concentration and processing of knowledge in the use of sunitinib or sorafenib?
  3. 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?
  4. Is there a link between problems with memory, concentration and processing of knowledge and also experiences of fatigue or mood of a patient?

Condition
Metastatic Renal Cell Cancer
GIST

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 50
Study Start Date: July 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
metastatic Renal Cell Carcinoma without treatment
patients with metastasized RCC who did not receive treatment
mRCC with treatment

patients with metastastic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for

≥ 8 weeks


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with mRCC are asked by their own physician.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246843

Locations
Netherlands
University Medical Centre Nijmegen
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: C.M.L. van Herpen, Md PhD University Medical Centre Nijmegen
  More Information

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01246843     History of Changes
Other Study ID Numbers: UMCNONCO200904
Study First Received: November 22, 2010
Last Updated: November 1, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
sunitinib
sorafenib
cognitive functioning

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sorafenib
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014