To assess the influence of sunitinib and sorafenib on subjective and objective cognitive functioning in patients with metastatic renal cell cancer or a GIST, in order to get more insight in the prevalence, type and etiology of cognitive…
ID
Source
Brief title
Condition
- Other condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Health condition
GIST
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
it is a pure describtive study, the results of the neuropsychological tests and
the results of the lab tests of the different study groups will be compared.
Secondary outcome
not applicable
Background summary
Targeted therapy concerns the application of a new class of drugs that are
specifically directed against one or more well-defined molecular targets that
are relevant for carcinogenesis, cell cycle regulation, tumour progression,
metastasis, tumour angiogenesis and/or apoptosis. Today, the most successful
drugs in this class are directed against the vascular endothelial growth factor
(VEGF) and the epidermal growth factor receptor (EGFR).
The toxicity profile of targeted therapies is still partly unknown, and the
aetiology of many known side effects has not been clarified. Given the impact
of side effects on the quality of life of a patient, increased knowledge on
this topic is urgently required. At the moment, three targeted therapies that
are directed against VEGF are registered and used in the Netherlands: Sunitinib
(Sutent®) and Sorafenib (Nexavar ®) both oral tyrosine kinase inhibitors (TKIs)
drugs and Bevacizumab (Avastin®), an intravenously antibody to the VEGF.
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 inhibition. Pre-clinically studies show
that VEGF influences growth and recovery of neurons.
Study objective
To assess the influence of sunitinib and sorafenib on subjective and objective
cognitive functioning in patients with metastatic renal cell cancer or a GIST,
in order to get more insight in the prevalence, type and etiology of cognitive
dysfunctioning during treatment with sunitinib or sorafenib.
Research questions:
•What is the prevalence of subjective and objective cognitive dysfunctioning
during treatment with sunitinib or sorafenib?
•What is the type of cognitive dysfunctioning during treatment with sunitinib
or sorafenib?
•What is the possible mechanism of sunitinib or sorafenib related cognitive
dysfunctioning, and is it related to special areas in the brains?
•Is cognitive dysfunctioning associated with demographic, psychological and /or
physical variables?
•Is cognitive dysfunctioning associated with fatigue or mood disorders?
•Is there a relation between VEGF level in blood and the presence of cognitive
dysfunctioning during treatment with sunitinib or sorafenib?
•Is there a relation between cytokine levels and the presence of cognitive
dysfunctioning during treatment with sunitinib or sorafenib?
Study design
The study design is a cross sectional explorative study with a healthy control
group and a control group patients with metastastic disease but no treatment
yet.
Study burden and risks
For patients it will take 2 hours. In these 2 hours different
neuropsychological tests will be done, which require concentration the tests
are furthermore not aggravating. Also some blood will be taken one time.
Besides a small change of a haematoma there are no further risks.
P.O. Box 9101
6500 HB Nijmegen
Nederland
P.O. Box 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Patients:
-patients with metastastic 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;Healthy controls selection:
-Healthy individuals:
- Karnofsky score > 70%
- age > 18 year
- written informed consent for study;Patient controls selection
Inclusion criteria:
-patients with metastastic 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
- 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 interleukine-2 treatment
- operation in the last 6 months
- Diabetes Mellitus
- Stroke/TIA;Healthy controls section:
- individuals who do not speak or write the Dutch language adequately
- use of psychiatric or anti-epileptic medication
- known cognitive disorders (Alzheimer e.g.)
- radiotherapy on the brain at any time in the past
- systemic chemotherapy
- operation in the last 6 months
- Diabetes Mellitus
- stroke/TIA;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 interleukine-2 treatment
- operation in the last 6 months
- Diabetes Mellitus
- stroke/TIA
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26369.091.08 |