Evaluation of Cognitive Function of Patients 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:

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?

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Key information

Conditions

Metastatic Renal Cell Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications GIST Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Nijmegen

Nijmegen, Gelderland, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Evaluation of Cognitive Function of Patients Treated With Sunitinib or Sorafenib

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Nov 23, 2010
Registry last updated: Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed