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Can Exercise Improve Cancer Associated Cognitive Dysfunction? (chemobrain)

5. juni 2016 opdateret af: University of British Columbia

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

31

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z4
        • University of British Columbia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Delayed exercise control
Participants asked to maintain usual lifestyle and provided with abbreviated version of intervention upon completion of end of study testing.
Eksperimentel: Exercise
Aerobic exercise Intervention as per below
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stroop Test
Tidsramme: Change from baseline at 6 months
Tests response inhibition, measure number of correct vs incorrect responses
Change from baseline at 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
FACT-Cog
Tidsramme: Change from baseline at 6 months
Self-reported cognitive function and quality of life
Change from baseline at 6 months
fMRI analyses
Tidsramme: Change from baseline at 6 months
regions of interest analysis, whole brain patterns of change
Change from baseline at 6 months
Graded exercise test
Tidsramme: Change from baseline at 6 months
Change from baseline at 6 months
Hopkins Verbal Learning Test
Tidsramme: Change from baseline at 6 months
Verbal Learning, measure number of recalled and recognized words
Change from baseline at 6 months
Trail Making A & B
Tidsramme: Change from baseline at 6 months
Visual Conceptual and Visuomotor Tracking, measure time taken to complete
Change from baseline at 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of British Columbia

Samarbejdspartnere

Canadian Breast Cancer Foundation

Efterforskere

  • Ledende efterforsker: Kristin Campbell, PT, PhD, University of British Columbia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. februar 2014

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

9. februar 2011

Først indsendt, der opfyldte QC-kriterier

15. februar 2011

Først opslået (Skøn)

16. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H10-02774

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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