To asses the effect of PCI on the brain with functional MRI (fMRI) and diffusion tensor imaging (DTI)-MRI and assess whether there is a correlation with patient-experienced fatigue.
ID
Source
Brief title
Condition
- Other condition
- Respiratory tract neoplasms
Synonym
Health condition
kleincellig longkanker patienten die profylactische schedelbestraling krijgen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in white matter integrity and bold response after PCI. Differences
between SCLC patients and controls for change in white matter integrity and
bold response.
Secondary outcome
- Relationship between changes in MRI parameters and changes in MVI-20, EORTC
c30, EuroQol-5D , HADS and CFQ
- Relationship between changes in MRI parameters and changes in IL-6, TNFα, CRP
and leukocytes/differential
Background summary
Cancer related fatigue (CRF) is a common problem in cancer patients. 50-90% of
these patients report fatigue, the highest percentage is found in patients
treated with chemo- and/or radiotherapy. Before starting cancer treatment,
cancer patients already report fatigue and cognitive problems. Symptoms often
worsen during and after treatment.
CRF may represent imbalances in inflammatory and inhibitory mechanisms induced
by cancer and/or chemo- and radiotherapy. For example, in some studies elevated
levels of fatigue have been reported in association with increased serum
measurements of pro-inflammatory cytokines like IL-6 and TNF-α. The hypothesis
is that these cytokines cause alterations in the central nervous system (CNS)
promoting fatigue. Recently, researchers started to investigate organic
substrate in fatigue using functional and structural magnetic resonance imaging
(MRI) of the brain as well in non-oncological as oncological patients. Fatigue
was linked with regions of decreased frontal and basal ganglia perfusion. MRI
is more sensitive in detecting functional differences than behavioural
measurements alone. Prophylactic cranial irradiation (PCI) is standard
treatment in small cell lung cancer (SCLC) patients with response or stable
disease after first line treatment (chemoradiotherapy in stage I-III,
chemotherapy in stage IV). These patients report in the first 3 months after
PCI significantly more fatigue than patients who have not had PCI, but there
are not many data regarding MRI and PCI. In this pilot study we want to
evaluate whether there is a substrate for fatigue on MRI and whether there is a
correlation with pro-inflammatory cytokines.
Study objective
To asses the effect of PCI on the brain with functional MRI (fMRI) and
diffusion tensor imaging (DTI)-MRI and assess whether there is a correlation
with patient-experienced fatigue.
Study design
prospective study
Study burden and risks
The MRI-techniques and questionnaires that are used in this study are
non-invasive. The risks of a MRI-scan are negligible because it is a magnetic
field, does not involve ionizing radiation and does not require contrast agents
or anesthesia.
The MRI will be performed twice, preferably the same day as when a regular
visit to the radiation oncologist is scheduled. Time per MRI is approximately
30 minutes. The MVI-20, EORTC c30 and EuroQol 5D questionnaires are validated
in cancer patients, duration per set of questionnaires is approximately 5
minutes. Screening for depression (HADS) and cognitive failure (CFQ) will also
be done (duration per questionnaire approximately 5 minutes). These
questionnaires will be taken at the same day as the MRI. All questionnaires
will also be taken at baseline; baseline also includes a personality test
(NEO-FFI, duration 10 minutes). Blood samples will be withdrawn twice, total
amount is 20 ml. There is no direct benefit for the patient. This is a study to
evaluate the usefulness of MRI in fatigue after PCI in order to incorporate
this assessment in intervention studies.
P Debijelaan 25
Maastricht 6229HX
NL
P Debijelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Stage I-III SCLC:
- Age >= 18 years
- stage I-III SCLC pathology proven
- Completed initial treatment with chemoradiotherapy, with at least stable disease (SD)
- WHO PS <= 2
- Ability to understand written questionnaires
- Written informed consent;Stage III NSCLC:
- Age >= 18 years
- stage I-III NSCLC pathology proven
- Completed treatment with chemoradiotherapy, with at least SD
- WHO PS <= 2
- Ability to understand written questionnaires
- Written informed consent;Healthy controls:
- Age >= 18 years
- WHO PS <= 2
- Ability to understand written questionnaires
- Written informed consent
Exclusion criteria
- prior radiotherapy to the brain
- claustrophobia
- pregnancy
- Metal implants or other contraindication for MRI
- inability to lie supine for 30 minutes time (MRI)
- antidepressants or steroids for the last two weeks
- clinically relevant anemia (defined as Hb < 5.5 mmol/l)
- chronic renal failure (defined as MDRD-eGFR < 30 ml/min/1.73m)
- liver biochemistry abnormalities (defined as more than two times upper limit of normal)
- major psychiatric illness requiring intervention in secondary care
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | aangemeld NTR, nummer volgt |
| CCMO | NL48269.068.14 |
| OMON | NL-OMON29029 |