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Chemotherapy-Induced Changes to Cognition and DNA in Breast Cancer Survivors

20 april 2022 bijgewerkt door: Memorial Sloan Kettering Cancer Center

Chemotherapy-Induced Cognitive Change and DNA Damage in Breast Cancer Survivors

The purpose of this study is to learn more about how chemotherapy affects an individual's thinking abilities (cognition). Some research has shown that chemotherapy can cause changes in cognition in breast cancer survivors. However, it is not clear why this change occurs. In this study, the investigators will look to see if damage to DNA is related to these changes in cognition. Specifically, the investigators want to see 1) if women who have been treated with chemotherapy have more DNA damage than healthy women; and 2) if DNA damage is related to cognitive problems in breast cancer survivors and healthy women.

Studie Overzicht

Gedetailleerde beschrijving

The primary objective of this proposal is to obtain preliminary data regarding the association between DNA damage and cognitive functioning in breast cancer survivors. Specifically, we predict that:

  1. Breast cancer survivors treated with chemotherapy and hormonal therapy will have higher levels of DNA damage as measured by the Comet assay as compared to age and education matched survivors treated with hormonal therapy only and healthy controls.
  2. Survivors who meet criteria for cognitive impairment will have higher levels of DNA damage as compared to cancer survivors who do not meet criteria for cognitive impairment and healthy controls.

Studietype

Observationeel

Inschrijving (Verwacht)

200

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • New York
      • Commack, New York, Verenigde Staten
        • Memorial Sloan Kettering Cancer Center at Commack
      • New York, New York, Verenigde Staten, 10021
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, Verenigde Staten, 11570
        • Memorial Sloan Kettering Cancer Center at Mercy Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Survivors Healthy women

Beschrijving

Inclusion Criteria:

  • Breast cancer survivors (Stage I-III) 2-6 years post all cancer treatments, but currently receiving hormone therapy.
  • History of treatment with chemotherapy and/or hormonal therapy, or hormone therapy only.
  • No evidence of active/recurrent disease.
  • Less than 70 years old at time of recruitment.
  • Post-menopausal prior to initial treatment.
  • In the judgment of the consenting professional, is able to provide informed consent.
  • Patient is able to understand English, through verbal and written communication.

Exclusion Criteria:

  • Recurrence of breast cancer or diagnosis of another cancer except basal cell carcinoma.
  • Exposure to chemotherapy or radiation therapy for any medical condition unrelated to breast cancer.
  • Neurobehavioral risk factors including history of neurological disorder, or moderate to severe head trauma (loss of consciousness > 60 min or evidence of structural brain changes on imaging).
  • Neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.
  • Self-reported sleep disorders that could influence cognitive functioning including sleep apnea and chronic fatigue syndrome.
  • Self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia.
  • Disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia.
  • Male.

Healthy Control Inclusion Criteria:

  • Have had no diagnosis of cancer except basal cell carcinoma.
  • Less than 70 years old at time of recruitment.
  • Post-menopausal.
  • In the judgment of the consenting professional, is able to provide informed consent.
  • Patient is able to understand English, through verbal and written communication

Healthy Control Exclusion Criteria:

  • Exposure to chemotherapy or radiation therapy for any medical condition.
  • Neurobehavioral risk factors including history of neurological disorder, or moderate to severe head trauma (loss of consciousness > 60 min or evidence of structural brain changes on imaging).
  • Neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, multiple sclerosis etc.
  • Self-reported sleep disorders that could influence cognitive functioning including sleep apnea and chronic fatigue syndrome.
  • Self-reported Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia.
  • Male.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
1
Breast cancer survivors (2-6 years post-treatment) who were post-menopausal at the time of diagnosis and treated with a combination of chemotherapy and hormonal therapy, matched on age and education
The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
2
Breast cancer survivors (2-6 years post-treatment) who were post-menopausal at the time of diagnosis and treated with hormonal therapy only matched on age and education
The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage
3
Healthy women matched on age and education
The neuropsychological testing will be conducted by a psychometrician who will be trained and supervised by Dr. Correa. It should take approximately 2 hours to complete.Two blood samples will be collected in green top tubes for analysis of DNA damage

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The primary goal of this preliminary study is to examine the relationship between DNA damage and chemotherapy-induced cognitive changes in breast cancer survivors.
Tijdsspanne: 2 years
2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2007

Primaire voltooiing (Werkelijk)

18 april 2022

Studie voltooiing (Werkelijk)

18 april 2022

Studieregistratiedata

Eerst ingediend

3 juli 2007

Eerst ingediend dat voldeed aan de QC-criteria

3 juli 2007

Eerst geplaatst (Schatting)

4 juli 2007

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 april 2022

Laatste update ingediend die voldeed aan QC-criteria

20 april 2022

Laatst geverifieerd

1 april 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 07-090

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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