Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

20. april 2022 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

200

Kontakter og lokationer

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

Studiesteder

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

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

50 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Survivors Healthy women

Beskrivelse

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.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

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

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.

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. juni 2007

Primær færdiggørelse (Faktiske)

18. april 2022

Studieafslutning (Faktiske)

18. april 2022

Datoer for studieregistrering

Først indsendt

3. juli 2007

Først indsendt, der opfyldte QC-kriterier

3. juli 2007

Først opslået (Skøn)

4. juli 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. april 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. april 2022

Sidst verificeret

1. april 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 07-090

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 .

Abonner