Can Exercise Improve Cancer Associated Cognitive Dysfunction?
40 Years
75 Years
Female
Breast Cancer
Trial Information
Can Exercise Improve Cancer Associated Cognitive Dysfunction?
Objective 1:
Conduct a randomized trial to test the effectiveness of a 24-week aerobic exercise
intervention in adult, female breast cancer survivors with self-reported cognitive changes
following chemotherapy.
The investigators will test the following hypotheses:
1. A) The exercise intervention will improve performance on neuropsychological tests of
specific cognitive domains of executive function, namely i)selective attention and
response inhibition, ii)processing speed and mental flexibility, and iii) verbal memory
and learning in exercisers (EX; n=15) versus delayed exercise controls (CON; n=15).
B) The exercise intervention will reduce self-reported cognitive dysfunction and its
impact of function and quality of life, in EX compared to CON, measured as a decreased
score on the Functional Assessment Cancer Therapy-Cognition Scale (FACT-Cog).
Objective 2:
Conduct analyses on the effect of the intervention on brain activation patterns using
functional magnetic resonance imaging (fMRI).
The investigators will test the following hypotheses:
2. A) At baseline, brain activation patterns will differ in breast cancer survivors
reporting cognitive difficulties following chemotherapy compared to breast cancer
survivors who have not received chemotherapy (who serve as breast cancer/no
chemotherapy controls; not enrolled in the exercise intervention) during
neuropsychological tests completed in the scanner.
B) The exercise intervention will result in a decrease in regions of cortical activation,
particularly in regions that show higher activation in breast cancer survivors following
chemotherapy, compared with no change in controls.
Inclusion Criteria:
- Women
- Completed chemotherapy within past 2 years
- completed for at least 3 months
- Self report cognitive dysfunction following chemotherapy
- Stage I-IIIA breast cancer
- Physically able to undertake moderate to vigorous physical activity program
Exclusion Criteria:
- Self report > 90min/week of moderate physical activity (last 6 months)
- Mini-mental status exam score < 23
- Co-morbid conditions that may alter cognitive testing results (i.e., a clinically
diagnosed major depression, anxiety disorder, or other psychiatric condition, meeting
DSM IV criteria)
- History of substance abuse
- Other neurological disorder (i.e., head injury, epilepsy, tumour, neurodegenerative
disease)
- Ruled ineligible for MRI scanning (i.e., metal implants)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Stroop Test
Outcome Description:
Tests response inhibition, measure number of correct vs incorrect responses
Outcome Time Frame:
Change from baseline at 6 months
Safety Issue:
No
Principal Investigator
Kristin Campbell, PT, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of British Columbia
Authority:
Canada: Health Canada
Study ID:
H10-02774
NCT ID:
NCT01296893
Start Date:
January 2011
Completion Date:
January 2014
Related Keywords:
- Breast Cancer
- Breast Neoplasms
- Cognition Disorders
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