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Completed

NCT Number: NCT01296893

Can Exercise Improve Cancer Associated Cognitive Dysfunction?

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

About this study

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:

  • 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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

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 outcomes

  1. Stroop Test

    Time frame: Change from baseline at 6 months

    Tests response inhibition, measure number of correct vs incorrect responses

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Breast Cancer Foundation

Registry information

Acronym: chemobrain

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Feb 16, 2011
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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