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Can Exercise Improve Cancer Associated Cognitive Dysfunction? (chemobrain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01296893
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : June 7, 2016
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

Following chemotherapy, some breast cancer survivors report alterations in their ability to remember, concentrate, or think, which can have significant emotional, psychological, and economic impact on their lives. Survivors have also reported feeling frustrated by the response of the medical community, who either may not acknowledge their symptoms or have no treatment options to suggest. Exercise may be a promising treatment, as improvements in cognitive function with exercise have been demonstrated in older adults and other clinical populations.

The investigators will recruit women who have completed chemotherapy for breast cancer (within the past 2 years) and report cognitive changes. Women will be randomly assigned to either a 24-week aerobic exercise intervention or delayed exercise control (offered the same exercise program following the study). At the start and end of the study the investigators will measure: i) performance on four standard neuropsychological tests that measure working memory, learning, and problem solving; ii) a questionnaire on cognitive function and its impact on quality of life; iii) functional magnetic resonance imaging (fMRI) during two of the standard neuropsychological tests which provides information on how the brain is working during the tests.

To knowledge of the investigators this is the first study to examine the effect of an exercise intervention on cognitive function in breast cancer survivors. In addition, the use of fMRI imaging is a new way to approach this research question, and may be more sensitive to change than traditional measures of cognitive function.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Exercise Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Exercise Improve Cancer Associated Cognitive Dysfunction?
Study Start Date : January 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Delayed exercise control
Participants asked to maintain usual lifestyle and provided with abbreviated version of intervention upon completion of end of study testing.
Experimental: Exercise
Aerobic exercise Intervention as per below
Behavioral: Exercise
150 minutes/week of aerobic exercise at 60-70% of heart rate reserve (individualized based on baseline VO2 peak test). The intervention is 24 weeks with an exercise progression to reach the full exercise prescription by week 8. Participants are required to attend two 45 minute supervised sessions per week and complete two additional 30 minute sessions independently at home.

Primary Outcome Measures :
  1. Stroop Test [ Time Frame: Change from baseline at 6 months ]
    Tests response inhibition, measure number of correct vs incorrect responses

Secondary Outcome Measures :
  1. FACT-Cog [ Time Frame: Change from baseline at 6 months ]
    Self-reported cognitive function and quality of life

  2. fMRI analyses [ Time Frame: Change from baseline at 6 months ]
    regions of interest analysis, whole brain patterns of change

  3. Graded exercise test [ Time Frame: Change from baseline at 6 months ]
  4. Hopkins Verbal Learning Test [ Time Frame: Change from baseline at 6 months ]
    Verbal Learning, measure number of recalled and recognized words

  5. Trail Making A & B [ Time Frame: Change from baseline at 6 months ]
    Visual Conceptual and Visuomotor Tracking, measure time taken to complete

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01296893

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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z4
Sponsors and Collaborators
University of British Columbia
Canadian Breast Cancer Foundation
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Principal Investigator: Kristin Campbell, PT, PhD University of British Columbia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of British Columbia Identifier: NCT01296893    
Other Study ID Numbers: H10-02774
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders