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Mild Cognitive Impairment in Breast Cancer Patients (HippoPCI)

1. april 2020 oppdatert av: Lei Wang, Northwestern University

Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients

The purpose of this study is to improve our understanding of potential changes in size, shape and activity in some brain areas that can occur in women receiving different types of Breast Cancer therapy, and how these changes are related to the development of mild cognitive impairment as the result of these treatments.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

This study aims to identify neuroimaging biomarkers for predicting mild cognitive impairment (MCI) in breast cancer patients receiving adjuvant chemo and/or hormonal therapy by examining hippocampal-cortical neurocircuitry. Adjuvant therapies increase long-term survival, but produce changes in cognitive function in 30% (up to 70%) of women on average with breast cancer. Cognitive decline negatively impacts quality of life in patients and their supporters. Therefore, early identification of patients at risk for developing treatment-related cognitive impairment is needed to develop potential prevention or treatment options and prevent further decline. Our recent work demonstrates that patients receiving adjuvant hormonal treatment exhibit decline in cognition as soon as three months post treatment. Although neuroimaging studies have identified brain changes associated with chemotherapy ("chemo brain", no investigation has assessed the type and severity of such changes following hormonal therapy, nor has any study determined which individuals are at greatest risk for cognitive impairment.

Our central hypothesis is that measures of the hippocampal-cortical integrity can be used to predict cognitive decline, and changes of specific domains of cognitive performance in patients receiving adjuvant therapy over time will be related to changes in specific components of this circuitry over time.

Studietype

Observasjonsmessig

Registrering (Faktiske)

84

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • Northwestern University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Participants will be recruited from the following sites, all affiliated with Northwestern University Feinberg School of Medicine (NUFSM): a) outpatient facility at Galter Pavilion of Northwestern Medicine; b) Maggie Daley Center for Women's Cancer Care at Prentice Women's Hospital; and c) Lynn Sage Comprehensive Breast Cancer Center at Prentice Women's Hospital.

Participants will also be recruited a) via advertisement in local newspapers, craigslist, Robert H. Lurie Comprehensive Cancer Center (RHLCC) Cancer Survivorship Institute website, and at community programs that serve cancer patients, including hospitals and support groups; and b) from community educational events sponsored by RHLCC, Women's Health Research Institute, and Cognitive Neurology and Alzheimer's Disease Center (CNADC).

Beskrivelse

Inclusion Criteria:

  • Female, within the age range of 40-70
  • HT Patients - any stage of breast cancer without brain metastasis, will undergo hormonal therapy without chemotherapy
  • CT and HT Patients - any stage of breast cancer without brain metastasis, will undergo chemotherapy and hormonal therapy
  • CT Patients - any stage of breast cancer without brain metastasis, has undergone surgery prior to screening, will undergo chemotherapy without hormonal therapy
  • RT or NT Patients - any stage of breast cancer without brain metastasis, will not undergo chemotherapy or hormonal therapy; may undergo radiation therapy or have no therapy
  • Controls - cognitively normal on the basis of annual neuropsychological and research neurological examinations done as part of the Uniform Data Set (UDS), of the NIA Alzheimer's Disease Centers (ADC) program, recruited from the NU CNADC Clinical Core.
  • All subjects must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

  • Individuals who report significant medical, neurologic, or psychiatric illness, including but not limited to:
  • Major depression
  • Schizophrenia
  • ADHD
  • Autism
  • Alzheimer's disease
  • Dementia
  • Obsessive-compulsive disorder
  • Post-traumatic stress disorder
  • Individuals with an Inventory of Depressive Symptomatology - Self Report (IDS-SR) score of 30 or higher, since this level of depression could affect cognitive test performance.

  • Brain surgery or head injury

    • Individuals reporting previous head injury
    • Individuals requiring neurosurgical procedures

  • Ineligibility for MRI scanning, including but not limited to:

    • Individuals who have non-MRI compatible medical implants or devices
    • Individuals who have any potential metal in their bodies
    • Individuals who have claustrophobia
    • Individuals with permanent makeup
  • Individuals reporting consumption of drugs that would affect cognition (neuropsychiatric or illicit)
  • Individuals indicating a history of breast cancer will be excluded from the healthy control group
  • Women who are pregnant or are planning to become pregnant during study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
HT Patients
any stage of breast cancer without brain metastasis, will undergo hormonal therapy without chemotherapy
CT and HT Patients
any stage of breast cancer without brain metastasis, will undergo chemotherapy and hormonal therapy
CT Patients
any stage of breast cancer without brain metastasis, has undergone surgery prior to screening, will undergo chemotherapy without hormonal therapy
RT or NT Patients
any stage of breast cancer without brain metastasis, will not undergo chemotherapy or hormonal therapy; may undergo radiation therapy or have no therapy
Controls
healthy, cognitively normal subjects

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rates of change in cognitive function from before treatment to after treatment initiation
Tidsramme: approximately 6 months
Measured using a neuropsychological test battery
approximately 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rates of change of brain structure from before treatment to after treatment initiation
Tidsramme: approximately 6 months
Measured using structural MRI scan
approximately 6 months
Rates of change of brain function from before treatment to after treatment initiation
Tidsramme: approximately 6 months
Measured using a functional MRI scan
approximately 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Northwestern University

Samarbeidspartnere

National Institute of Nursing Research (NINR)

Etterforskere

  • Hovedetterforsker: Lei Wang, PhD, Northwestern University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2013

Primær fullføring (Faktiske)

31. desember 2019

Studiet fullført (Faktiske)

31. desember 2019

Datoer for studieregistrering

Først innsendt

19. september 2013

Først innsendt som oppfylte QC-kriteriene

19. september 2013

Først lagt ut (Anslag)

24. september 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. april 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1R01NR014182-01 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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