Can Exercise Improve Cancer Associated Cognitive Dysfunction?

NCT01296893 | Completed Phase 2

• 1 other identifier: H10-02774
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Stroop Test

  Tests response inhibition, measure number of correct vs incorrect responses

  Change from baseline at 6 months

Secondary Outcomes (5)

• FACT-Cog

  Change from baseline at 6 months

• fMRI analyses

  Change from baseline at 6 months

• Graded exercise test

  Change from baseline at 6 months

• Hopkins Verbal Learning Test

  Change from baseline at 6 months

• Trail Making A & B

  Change from baseline at 6 months

Study Arms (2)

Delayed exercise control

NO INTERVENTION

Participants asked to maintain usual lifestyle and provided with abbreviated version of intervention upon completion of end of study testing.

Exercise

EXPERIMENTAL

Aerobic exercise Intervention as per below

Behavioral: Exercise

Interventions

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.

Exercise

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Related Publications (1)

• Campbell KL, Kam JWY, Neil-Sztramko SE, Liu Ambrose T, Handy TC, Lim HJ, Hayden S, Hsu L, Kirkham AA, Gotay CC, McKenzie DC, Boyd LA. Effect of aerobic exercise on cancer-associated cognitive impairment: A proof-of-concept RCT. Psychooncology. 2018 Jan;27(1):53-60. doi: 10.1002/pon.4370. Epub 2017 Feb 10.

  PMID: 28075038 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kristin Campbell, PT, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 16, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2015
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

CA (1)