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A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients

10. december 2013 opdateret af: National University Hospital, Singapore

The primary objective of this prospective pilot study is to examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference. All randomized patients and their respective controls would be required to complete the computerized neuropsychological assessment CANTAB at certain time-points.These patients and controls would also be given on the same day as CANTAB testing, a set of questionnaires to evaluate subjective factors such as anxiety, depression, fatigue or menopausal symptoms which may also have an effect on cognition. Subjective assessment of cognitive function will rely on self-reporting by study participants using a validated questionnaire.The potential risks to subjects are minimal, as this is a study without any intervention regarding the medical management of patients. By participating in this study, subjects will be helping in the aim of determining if there is cognitive impairment post-therapy, and if so, how prevalent is this phenomenon, when it arises and how it changes with time. This will consequentially play an important role with regard to patient knowledge. Furthermore, if chemotherapy is shown to be associated with cognitive impairment, further studies can be carried out to determine the exact pathophysiology behind this phenomenon. This will allow for sensitive and timely detection of cognitive dysfunction in patients who have received chemotherapy and/or anti-hormonal therapy, and subsequently open the avenue for research in preventing or alleviating this phenomenon. This is crucial in improving patients' quality of life, social and occupational performance.

The investigators hypothesis is that systemic adjuvant therapy in the form of chemotherapy and/or anti-hormonal therapy given to primary breast cancer patients can cause cognitive impairment.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

100

Kontakter og lokationer

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

Studiesteder

  • Singapore
      • Singapore, Singapore
        • Rekruttering
        • Nationa University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Sing Huang Tan, MBBS

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

21 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Patients being treated with breast cancer at National University Hospital (Singapore)and healthy women would be used consisting of a friend or relative of the patient.

Beskrivelse

Inclusion Criteria:

  1. Histologically confirmed stage I-III breast carcinoma
  2. < 65 years old
  3. Female

Exclusion Criteria:

  1. Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy
  2. Previous neoadjuvant therapy for breast cancer
  3. Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ
  4. Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders
  5. Motor weakness due to any cause which makes using a touchscreen computer difficult
  6. Known background of depression, anxiety disorders or other neurobehavioural conditions
  7. Ongoing use of tranquilisers or anti-depressants
  8. Previous neuropsychological testing
  9. Current or previous history of alcohol or drug dependent

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy
To examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference.

Sekundære resultatmål

Resultatmål
Determine which cognitive domains in particular are affected
Assess certain other measures such as anxiety, depression, fatigue or menopausal symptoms which may have an impact on cognitive function using a set of validated questionnaires
Compare self-perceived cognitive deficits with objective measurements
Evaluate underlying biological pathways and susceptibility to cognitive dysfunction through blood biomarker studies, genetic polymorphisms and other mechanisms which we deem to be relevant

Samarbejdspartnere og efterforskere

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

Sponsor

National University Hospital, Singapore

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. juni 2013

Primær færdiggørelse (Forventet)

1. maj 2014

Studieafslutning

7. december 2022

Datoer for studieregistrering

Først indsendt

2. april 2012

Først indsendt, der opfyldte QC-kriterier

10. maj 2012

Først opslået (Skøn)

11. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Version 01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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