cognitive decline memory and concentration problems
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -participation in study PROSPECT, NL32148.031.10;Inclusion criteria PROSPECT study (all groups): -female -age
Exclusion criteria
Exclusion criteria: All groups: -new malignancies, except for basal cell carcinoma -excessive use of alcohol of drugs -use of psychotropic medication -neurologic or psychiatric disorders that may influence cognitive functioning -conditions that preclude MRI examination (e.g., pacemaker);Experimental group and breast cancer control group: -relapse and/or metastases -treatment with trastuzumab (Herceptin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Cognitive decline 3 years after chemotherapy (dependent variable) Cognitive decline 3 years after chemotherapy completion is evaluated with standardised neurocognitive tests. These are well-known tests that are often used at the department of Psychosocial Research and Epidemiology of the Netherlands Cancer Institute. Overall cognitive decline can range from 0 to 18 based on cognitive decline on the number of individual outcome measures (for details see Statistical Analysis section). The following tests are administered: Flanker test, Digit Span and Digit Symbol of the Wechsler Adult Intelligence Scale III, Behavioural Assessment of the Dysexecutive Syndrome (BADS) Zoo map test, Controlled oral word association test (COWAT), Hopkins Verbal Learning Test Revised (HVLT-R,Trail making test, Visual Reproduction of the Wechsler Memory Scale, Fepsy Finger Tapping Task, Fepsy Visual Reaction Time Task. The official Dutch versions of the tests are used. For each of the 18 outcome measures cognitive decline is calculated with the reliable change index corrected for practice effects. When a patients score drops below a 90% confidence interval of the baseline score (assessed at baseline before chemotherapy exposure in the PROSPECT study) this is considered significant cognitive decline. When a patients declines on all outcome measures she scores 18, when she doesn*t decline on any outcomes measure she scores 0. 2) White matter reserve (independent variable) White matter reserve (premorbid microstructural white matter integrity before chemotherapy exposure) is measured with diffusion MRI scans. These scans are collected in an ongoing study (PROSPECT, NL32148.031.10). | — |
Secondary
| Measure | Time frame |
|---|---|
| (*) Cognitive decline 2 years after chemotherapy (dependent variable) Cognitive decline 2 years after chemotherapy is measured in the same way as the 3 year measurement (see above). (*)Early decline of white matter integrity Early decline of white matter integrity (6 months after chemotherapy) is measured with diffusion MRI scans (difference baseline measurement and measurement 6 months after chemotherapy). These scans have been acquired in an ongoing study (PROSPECT, NL32148.031.10). (*) Late decline of white matter integrity as measured with diffusion MRI and other MRI markers for late decline of the brain MRI scans are acquired on a Philips 3 Tesla scanner with an 8 channel SENSE head coil. MRI scan sequences: 1. Diffusion tensor imaging (DTI) is used to measure late decline of white matter integrity (3 years after chemotherapy). 2. 3-dimsional inversion recovery T1 weighted sequence for (automated) volumetrics as a global marker for tissue injury. 3. FLAIR sequence for rating of white matter lesions. 4. Proton MR spectroscopy for evaluation of brain chemistry. Metabolites that can be measured are N-acetyl aspartate (NAA), choline (Cho) and myo-inositol (MI). NAA is a marker for neuronal function. Choline is a marker for demyelination. MI is a glia marker. 5. Functional MRI (fMRI): 3 fMRI scans will be acquired that are sensitive to the BOLD signal (blood oxygenation level dependent) and are a proxy for local brain activation. One scan is acquired while participants perform an fMRI version of the Tower of London, an executive functioning test to measure activation of the prefrontal lobe, 1 scan during performance of a paired associates test, a memory test (encoding and retrieval) to measure activation of (para)hippocampal structures, 1 resting state scan to measure activity of neural network during rest. The following data will be collected for all participants 2 and 3 years after chemotherapy (or matched intervals for cancer patients w | — |
Countries
Netherlands
Outcome results
None listed