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

• Sponsor: National University Hospital, Singapore (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01596439
• Collaborator: (none)
• Enrollment: 100
• Location: 1

Study Details

Study Description

Brief Summary

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	Intervention/Treatment	Phase
Breast Cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: May 1, 2014

Outcome Measures

Primary Outcome Measures

1. 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.

Secondary Outcome Measures

1. Determine which cognitive domains in particular are affected []

2. 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 []

3. Compare self-perceived cognitive deficits with objective measurements []

4. Evaluate underlying biological pathways and susceptibility to cognitive dysfunction through blood biomarker studies, genetic polymorphisms and other mechanisms which we deem to be relevant []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationa University Hospital	Singapore		Singapore

Sponsors and Collaborators

• National University Hospital, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: National University Hospital, Singapore
• ClinicalTrials.gov Identifier: NCT01596439
• Other Study ID Numbers: Version 01
• First Posted: May 11, 2012
• Last Update Posted: Dec 11, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by National University Hospital, Singapore: Healthy women; consisting of a friend or relative of the patient
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Dec 11, 2013