Mild Cognitive Impairment in Breast Cancer Patients (HippoPCI)
Hippocampal Predictors of Cognitive Impairment (HippoPCI) in Breast Cancer Patients
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60611
- Northwestern University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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).
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rates of change in cognitive function from before treatment to after treatment initiation
Zeitfenster: approximately 6 months
|
Measured using a neuropsychological test battery
|
approximately 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rates of change of brain structure from before treatment to after treatment initiation
Zeitfenster: approximately 6 months
|
Measured using structural MRI scan
|
approximately 6 months
|
|
Rates of change of brain function from before treatment to after treatment initiation
Zeitfenster: approximately 6 months
|
Measured using a functional MRI scan
|
approximately 6 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Lei Wang, PhD, Northwestern University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1R01NR014182-01 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Brustkrebs
-
Novartis PharmaceuticalsAbgeschlossenMetastasierter Brustkrebs (MBC) | Locally Advance Breast Cancer (LABC)Vereinigtes Königreich, Spanien
-
BioNTech SESeventh Framework ProgrammeAbgeschlossenBrustkrebs (Triple Negative Breast Cancer (TNBC))Schweden, Deutschland
-
Filipa Lynce, MDAstraZeneca; Daiichi Sankyo, Inc.RekrutierungBrustkrebs | HER2-positiver Brustkrebs | Invasiver Brustkrebs | Entzündlicher Brustkrebs Stadium III | HER2 Low Breast AdenokarzinomVereinigte Staaten