To identify what might be the cause of the occurrence of diarrhea during the use of angiogenesis inhibitors sunitinib and sorafenib in patients with a malignancy.
ID
Source
Brief title
Condition
- Other condition
- Malabsorption conditions
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Health condition
GIST, hepatocellulair carcinoom of medullair schildkliercarcinoom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Descriptive: from the outcomes of laboratory investigations, H2-breath test and
scopies we hope to identify the cause of the diarrhea, e.g. secretoir,
absorption failure or inflammation.
Secondary outcome
nvt
Background summary
The recent development of angiogenesis inhibitors represents a major
breakthrough in the treatment of cancer. Sunitinib (Sutent ®) and sorafenib
(Nexavar ®) are two registered angiogenesis inhibitors. Sunitinib is a multiple
tyrosine kinase inhibitor that is approved for the treatment of metastatic
renal cell carcinoma and imatinib-resistant gastrointestinal stromal tumours
(GIST).
Sorafenib is a multiple tyrosine kinase inhibitor and registered for metastatic
renal cell carcinoma and for treatment of unresectable or metastatic
hepatocellular carcinoma.Very recently, sorafenib has also been indicated for
treatment-resistant non medullary thyroid carcinoma.
Now that both sunitinib and sorafenib are used frequently, the side effects
become increasingly visible. One of the most common side effects is diarrhea.
Diarrhea leads to a reduced quality of life. That is very clear in case of
severe diarrhea grade 3 or 4. But long-term mild diarrhea (grade 1 or 2) also
leads to a significantly decreased quality of life. Patients may become
socially invalidated by the increased use of toiletfacilities or because they
suffer from abdominal cramps and flatulence. Often they can not tolerate
certain foods. Besides the impact on quality of life, diarrhea may be such that
dose reduction is necessary or that the therapy should be discontinued. This
has an adverse effect on the antitumor efficacy of treatment and duration of
progression-free survival and possibly even survival. Moreover, changes in the
gastrointestinal tract lead to changes in the pharmacokinetics and - dynamics
of these drugs, so the effectiveness of these drugs may be affected. The
treatment and prevention of diarrhea is therefore of the utmost importance.
The exact pathophysiological mechanism of the diarrhea is so far unknown, and
this hinders the development of better therapies and preventive measures. The
purpose of this study is to gain more knowledge about the pathophysiological
mechanism of diarrhea in patients treated with angiogenesis inhibitors
sunitinib and sorafenib.
Study objective
To identify what might be the cause of the occurrence of diarrhea during the
use of angiogenesis inhibitors sunitinib and sorafenib in patients with a
malignancy.
Study design
This is an inventory, cross-sectional study
Study burden and risks
The burden in time for patients is about 5 hours in the hospital. Part of the
tests can be combined with each other. Depending on the results of the tests,
patients will be at the hospital between 3 and 5 times. The risks of the tests
are low and comparable with the risks for a population of patients outside this
study.
p/a UMC St Radboud Postbus 9101 hp 485
6500 HB Nijmegen
NL
p/a UMC St Radboud Postbus 9101 hp 485
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Patients with renal cell carcinoma, GIST, hepatocellular carcinoma or medullary thyroid carcinoma treated with sunitinib or sorafenib
Diarrhea CTC grade >= 1, generated during the use of angiogenesis inhibitor
Age >= 18 years
Signed informed consent
Exclusion criteria
Known history of relevant disorders: absorption disorders such as inflammatory bowel disease, celiac disease or lactose intolerance
Use of laxatives
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 | NL35610.091.11 |