To study late term complications after radiotherapy of the neck
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence, location and composition of extra- and intracranial postirradiation
vessel wall assessed by MRI/A and duplexultrasonography.
Secondary outcome
- Incidenc of white matter lesions, (silent) brain infarctions and atrophy,
assessed bij MRI/A
- Incidence cardio and cerebrovascular diseases
- Scores on balans and gaith parameters
- Incidence cognitive dysfunctioning, assessed by a neuropsychological
excamination
Background summary
Radiation induced carotid vasculopathy with subsequent increased risk of
cerebrovascular accidents is a well known late complication of Radiotherapy
(RT) of the neck. More knowledge of the underlying pathofysiology is needed to
develop prevention strategies and to identify patients at risk. We have an
unique prospective cohort of patients treated for head and neck malignancies
with prior irradiation of the neck. Baseline and 2 years after RT Intima Media
Thickness (IMT) measurements of both carotid arteries are performed. We will
expand the follow up period of this cohort to 5 years after RT to answer the
following questions.
The first question to be answered is what is the relation between RT and
imaging characteristics of atherosclerosis? The hypothesis is that irradiation
induces premature atherosclerosis. It is unclear whether the location and
composition of these postirradiation vessel wall changes are different from
those in more common atherosclerosis due to cardiovascular risk factors. With
advanced imaging techniques we will assess the extra- and intracranial
arteries in all patients.
The second question to be answered is what is the relation between RT and
asymptomatic cerebral vascular changes? It is known that the prevalence of
silent brain infarcts is up to fivefold higher than the prevalence of stroke in
the community. These changes have a major impact on cognitive functioning and
gaith and balance disorders. Carotid artery pathology increases this risk. To
assess this, all the study patients will undergo MRI of the brain to score
white matter lesions, silent brain infarcts and cerebral atrophy.
The third question to be answered is what is the relation between RT and
symptomatic vascular events? When carotid or cerebral arteries are within the
RT field, there is an increased risk to develop cerebrovascular accidents.
Within the first 2 years after RT of the neck, we found a 8 times higher
incidence of stroke and a 16 times higher incidence of TIA, when compared to
the community. Cerebrovascular risk factors and vascular diseases will be
assessed in all patients.
The fourth question to be answered is what is the relation between RT induced
cerebral vascular lesions and gaith disturbances? To assess this we will
perform quantitative gaith analysis in all patients.
The fifth question to be answered is what is the relation between RT and
cognitive functioning? We know that silent brain infarcts in the community are
associated with worse cognitive ability and increased risk of developing
dementia. Therefore, we will perform neuropsychological tests in all the study
participants.
Study objective
To study late term complications after radiotherapy of the neck
Study design
Design: Prospective cohort study
All patients had already baseline (before RT) and 2 years after RT follow-up.
At every visit they underwent a structured interview, neurological
excamination, laboratory investigatuin ans duplex ultrasonography.
At the 6 year follow-up patient will undergo:
- Structured interview and neuroloical excamination, including ECG
- Fasting laboratory investigation (glucoses, cholesterol)
- MRI/A of brain and extra- and intracranial arteries
- Duplex Ultrasonography of carotid arteries (IMT, strain imaging)
- Gaith analysis
- Neuropsychological Excamination and questionaries (HADS, CIS)
Study burden and risks
When clinincal relevant abnormalities are found on the laboratory
investigation, ECG, duplex ultrasonography or MRI/A, the studycoordinator will
inform the patient and the general practicioner. All MRI/A's will be officially
asessed by a neuro-radiologist.
Reinier postlaan 4
6525 GC Nijmegen
NL
Reinier postlaan 4
6525 GC Nijmegen
NL
Listed location countries
Age
Inclusion criteria
RT of the neck because of a T1/T2 (N0M0) laryngeal carcinoma, T1/T2 (N0M0) parotid carcinoma / pleomorphic adenoma, T1/2 (N1/2M0) oro/hypopharynxcarcinoma or non-Hodgkin/Hodgkin lymphoma and a minimal follow-up of 6 years post RT.
Exclusion criteria
History of cerebrovascular disease, pregnancy or breast-feeding, ongoing treatment with an HMG-coA reductase or cytochroom P450 inhibitor, active liver disease or > 3 times the upper limit of serum transaminases, 5 times the normal level of creatine phosphokinase, serum cholesterol > 7 mmol/L and a life expectancy < 2 years. Contra-indication for (contrast enhanced) MRI/A.
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 | NL41008.091.12 |