Effect of physical exercise on cognitive function after chemotherapy in patients with breast cancer
- Conditions
- 10006291breast cancer / cognitive functioncognitive function
- Registration Number
- NL-OMON50463
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
Inclusion criteria for the study are: breast cancer patients adjuvantly treated
with chemotherapy plus or minus endocrine therapy, 2-4 years after cancer
diagnosis, 30-75 years of age, no indication of relapse or metastases, exercise
* 150 min/week self-reported cognitive problems, lower than expected
performance on neuropsychological testing, mastering the Dutch language and
willing to be randomly assigned to one of the two study arms.
We will exclude patients with known neurological conditions and/or diseases
that affect cognition (e.g. dementia, MS, TBI), disorders that might impede
exercise participation, patients with breast cancer in both breasts, contra
indications for MR imaging (see Appendix 2 Protocol); and patients switching
from Tamoxifen to aromatase inhibitors during the study period or four months
before.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome parameters are: cognitive functioning (the total recall score<br /><br>of the HVLT-R as our primary outcome measure), self-reported cognitive<br /><br>complaints (MDASI-MM module, 2 symptom severity questions on memory and<br /><br>attention and 6 symptom interference items). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters include overall cognitive functioning measured with<br /><br>standard neuropsychological tests, brain structure and function (3 Tesla brain<br /><br>MRI), anthropometrics, physical fitness, QOL, fatigue, anxiety and depressive<br /><br>symptoms, and work performance. </p><br>