Primary objective1.To determine the characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis inhibitors and EGFR inhibitors.Secondary objectives1.To investigate if steroid profile, indol profile,…
ID
Source
Brief title
Condition
- Endocrine and glandular disorders NEC
- Bone, calcium, magnesium and phosphorus metabolism disorders
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients will be evaluated for vascular changes by measuring 24-hour ambulatory
blood pressure, baroreflex sensitivity, nail fold capillary microscopy and
arterial compliance measurement at 3 time points: before start of treatment,
and after 3 and after 6 weeks of treatment. Patients will also be asked to
measure their blood pressure at home twice a day, for 6 weeks. Metabolic and
hormonal changes and investigation of biomarkers will be done by blood and
urine analyses every 3 weeks for the first 3 months, every 6 weeks up to 6
months and every 3 months thereafter, and by skin autofluorescence before
treatment and after 3 and after 6 weeks of treatment.
Changes in vascular, hormonal and metabolic status will be related to clinical
side effects and to response to treatment.
Secondary outcome
When clinically relevant differences in side effects and response to treatment
are found among patients treated with the same agent, DNA analysis will be
carried out to investigate if changes in candidate genes are related to these
differences.
Background summary
In recent years, multiple new agents have been developed that inhibit specific
targets involved in cell growth, proliferation and angiogenesis, together
called targeted therapy.
The cell signalling routes that are inhibited by these agents however, are not
only active in cancer cells but are also involved in physiological processes in
normal tissue and organs. This means that these drugs do not only have an anti
tumour effect but also modify several physiological processes that lead to side
effects. Little is known about these side effects that generally are less
severe than side effects of cytotoxic chemotherapy, but because targeted
therapy is often administered for prolonged periods of time, these side effects
can seriously affect quality of life.
Study objective
Primary objective
1.To determine the characteristics, frequency and severity of vascular,
metabolic and hormonal side effects of angiogenesis
inhibitors and EGFR inhibitors.
Secondary objectives
1.To investigate if steroid profile, indol profile, concentrations of
catecholamines and metanephrines or thyroid antibodies
changes during treatment with angiogenesis inhibitors and EGFR inhibitors.
2. To investigation if known biomarkers change during treatment.
3. To investigate whether vascular function changes during treatment with
angiogenesis inhibitors and EGFR inhibitors.
4. To determine if changes in skin autofluorescence and development of AGE*s
occur during treatment with
angiogenesis inhibitors and EGFR inhibitors.
5. To determine whether changes in factors mentioned under secondary objectives
1-4 are correlated with side effects of
angiogenesis inhibitors and EGFR inhibitors and/or response to angiogenesis
inhibitors and EGFR inhibitors.
6. To evaluate if polymorphisms in genes involved in pathways mentioned under
1-4 associate with toxicity and efficacy of
angiogenesis inhibitors and EGFR inhibitors.
Study design
This is a prospective, explorational, observational cohort study.
Study burden and risks
The minimal invasive tests will be performed during routine outpatient visits.
As far as known no serious adverse events are linked to described study
procedures. With this study we hope to get insight into the characteristics,
frequency, severity and underlying mechanisms of angiogenesis inhibitor and
EGFR inhibitor induced vascular, metabolic and hormonal side effects and to
find usable surrogate markers for efficacy of treatment. Eventually, this may
contribute to the early detection of vascular, metabolic and hormonal changes,
to the design of intervention strategies for side effects and to better patient
selection for angiogenesis inhibitors and EGFR inhibitors .
Hanzeplein 1
9700 RB GRONINGEN
NL
Hanzeplein 1
9700 RB GRONINGEN
NL
Listed location countries
Age
Inclusion criteria
- Patients treated with angiogenesis or EGFR inhibitors.
Concomitant chemotherapy, immunotherapy or radiotherapy is allowed.
- Age above 18 years at start of treatment
- Willingness to give written informed consent
Exclusion criteria
-Unable to give written informed consent
- Age under 18 years
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 |
|---|---|
| Other | 2007/203 |
| CCMO | NL18988.042.07 |