A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01596439|
Recruitment Status : Unknown
Verified December 2013 by National University Hospital, Singapore.
Recruitment status was: Recruiting
First Posted : May 11, 2012
Last Update Posted : December 11, 2013
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||May 2014|
- 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 therapyTo 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596439
|Contact: Sing Huang Tan, MBBS||+65 6779 5555||Sing_Huang_Tan@nuhs.edu.sg|
|Nationa University Hospital||Recruiting|
|Contact: Sing Huang Tan, MBBS +65 6779 5555 Sing_Huang_Tan@nuhs.edu.sg|
|Principal Investigator: Sing Huang Tan, MBBS|