- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01596439
A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Singapore, Singapore
- Reclutamento
- Nationa University Hospital
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Contatto:
- Sing Huang Tan, MBBS
- Numero di telefono: +65 6779 5555
- Email: Sing_Huang_Tan@nuhs.edu.sg
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Investigatore principale:
- Sing Huang Tan, MBBS
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Histologically confirmed stage I-III breast carcinoma
- < 65 years old
- Female
Exclusion Criteria:
- Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy
- Previous neoadjuvant therapy for breast cancer
- Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ
- Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders
- Motor weakness due to any cause which makes using a touchscreen computer difficult
- Known background of depression, anxiety disorders or other neurobehavioural conditions
- Ongoing use of tranquilisers or anti-depressants
- Previous neuropsychological testing
- Current or previous history of alcohol or drug dependent
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
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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
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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.
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Misure di risultato secondarie
Misura del risultato |
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Determine which cognitive domains in particular are affected
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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
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Compare self-perceived cognitive deficits with objective measurements
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Evaluate underlying biological pathways and susceptibility to cognitive dysfunction through blood biomarker studies, genetic polymorphisms and other mechanisms which we deem to be relevant
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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Bhoo-Pathy N, Hartman M, Yip CH, Saxena N, Taib NA, Lim SE, Iau P, Adami HO, Bulgiba AM, Lee SC, Verkooijen HM. Ethnic differences in survival after breast cancer in South East Asia. PLoS One. 2012;7(2):e30995. doi: 10.1371/journal.pone.0030995. Epub 2012 Feb 21.
- Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 Sep 19;352(9132):930-42.
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Aggiornamenti dei record di studio
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Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Version 01
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