ate effects of chemotherapy on brain functioning in the elderly

• Conditions: cognitive deficits; memory and concentration problems; 10042258; 10009841

• Registration Number: NL-OMON31638
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

female
sufficient proficiency in Dutch language
treatment with adjuvant CMF chemotherapy for breast cancer five to twenty years ago
over 60 years old

Exclusion Criteria

relapse and/or metastases
conditions that preclude MRI examination

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>MRI measures (1.5 Tesla):<br /><br>-2D proton density weighted (PDW) scan: 90 slices/1.6 mm<br /><br>-FLAIR scan: 64 slices/2.5 mm<br /><br>-3D T1W scan:100 slices/1.6 mm<br /><br>-3D T2*W (Susceptibility Weighted SWI) scan:100 slices/1.6 mm<br /><br>-2D Phase Contrast Flow Measurement<br /><br>-Diffusion tensor imaging (25 diffusion tensor directions):39 slices/3.5mm<br /><br><br /><br>These measures will be used to assess total and regional grey matter, white<br /><br>matter and CSF volume and presence and severity of vascular lesions (white<br /><br>matter lesions, lacunar infarcts, microbleeds).<br /><br><br /><br>Neuropsychological measures:<br /><br>Mini-Mental State examination<br /><br>the Stroop test<br /><br>the Letter digit substitution task<br /><br>verbal fluency task<br /><br>15 word verbal learning test<br /><br><br /><br>These tests will be used to assess impairments in verbal skills, executive<br /><br>functions, attention and memory.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Age<br /><br>Educational status<br /><br>Smoking habits<br /><br>Alcohol intake<br /><br>Body mass index<br /><br>Bloodpressure<br /><br>Blood glucose level<br /><br>Activity of hart muscle<br /><br>Condition of coronary arteries<br /><br>Known genetic riskfactors for cognitive decline/dementia<br /><br>Age of menopause<br /><br>Type of menopause (natural or artificial)<br /><br>Use of hormone replacement therapy<br /><br>Depressed mood<br /><br>Self-reported cognitive problems<br /><br>Self-reported medical history and medication use<br /><br>Number of CMF cycles<br /><br>Radiotherapy yes/no<br /><br>Endocrine therapy yes/no </p><br>