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Can Exercise Improve Cancer Associated Cognitive Dysfunction? (chemobrain)

This study is currently recruiting participants.
Verified February 2012 by University of British Columbia
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01296893
First received: February 9, 2011
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Behavioral: Exercise
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Can Exercise Improve Cancer Associated Cognitive Dysfunction?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Stroop Test [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    Tests response inhibition, measure number of correct vs incorrect responses


Secondary Outcome Measures:
  • FACT-Cog [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    Self-reported cognitive function and quality of life

  • fMRI analyses [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    regions of interest analysis, whole brain patterns of change

  • Graded exercise test [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
  • Hopkins Verbal Learning Test [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    Verbal Learning, measure number of recalled and recognized words

  • Trail Making A & B [ Time Frame: Change from baseline at 6 months ] [ Designated as safety issue: No ]
    Visual Conceptual and Visuomotor Tracking, measure time taken to complete


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296893

Contacts
Contact: Kristin Campbell, PT, PhD 604-827-4704 kristin.campbell@ubc.ca

Locations
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 1Z4
Contact: Kristin Campbell, PT, PhD     604-827-4704     kristin.campbell@ubc.ca    
Principal Investigator: Kristin Campbell, PT, PhD            
Sponsors and Collaborators
University of British Columbia
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Kristin Campbell, PT, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01296893     History of Changes
Other Study ID Numbers: H10-02774
Study First Received: February 9, 2011
Last Updated: February 29, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Breast Neoplasms
Cognition Disorders
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013