Evaluation of Cognitive Function of Patients With Sunitinib or Sorafenib

November 1, 2011 updated by: Radboud University Medical Center

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:

  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?

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • University Medical Centre Nijmegen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with mRCC are asked by their own physician.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCNONCO200904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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