Evaluation of Brain Function Before and After Standard Chemotherapy for Early Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Brief Summary

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Primary Objective

* To investigate and clearly document the presence and extent of cognitive decline, if any, in women of Asian origin following standard-dose systematic adjuvant chemotherapy for the treatment of breast cancer
* Investigation and establishment of a relationship between degree of oxidative DNA and lipid damage as indicated by plasma and urinary biochemical markers.

Secondary Objective

• To validate the use of hydrogen peroxide and serum amyloid as biomarkers of damage

Detailed Description

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As the survival rate and prognosis of cancer improve, there is increasing recognition of the presence of a long term negative impact of standard chemotherapy on cognition, namely in the domains of attention, memory, psychomotor speed and executive functions. The purported incidence varies between 10-50%, the mechanism is unknown and it is unclear who is at risk. This impact has also not been studied and documented in the Asian population.

This proposal outlines a study that intends to prospectively (1) investigate and document the incidence and severity of cognitive impairment following systemic chemotherapy for breast cancer in Asian women in the acute and prolonged setting, and (2) to relate these cognitive changes to damage to DNA and lipids (two major targets of attack by toxic agents) as indicated through tests conducted on blood and urine samples.

Thirty breast cancer patients who will be required to undergo standard chemotherapy will be recruited for a pilot study to determine the acceptability of the procedure and to establish the size of the effects under investigation. A 45-minute neurocognitive assessment will be administered at three time points: before commencement of chemotherapy, and at 6 months and 1 year following completion of chemotherapy. Blood and urine samples will be collected just prior to the commencement of chemotherapy, after the first cycle of chemotherapy, and also at 6 months and 1 year post completion of chemotherapy.

It is hypothesized that (1) there will be decrements in performance on the neurocognitive measures post-chemotherapy; (2) the presence of cognitive decline will correlate with the presence of markers of oxidative damage in the blood and urine samples. The benefits of this project are two fold. Firstly, it will allow research into and documentation of the possible presence of cognitive decline following chemotherapy in Asian women, which is important in allowing patients to make fully-informed consent with regard to treatment. Secondly, if a relationship between the presence of cognitive decline and the presence of biochemical markers of oxidative damage can be established, this can potentially lead to new treatment methods that may reduce the cognitive decline that has been associated with the chemotherapeutic process.

Conditions

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Early Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Early breast cancer

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Histologically documented breast cancer
2. Females greater than 18 years old
3. Eastern Cooperative Oncology Group (ECOG) Performance status 0,1,2
4. Requires to undergo standard-dose systemic adjuvant chemotherapy
5. Patients must be informed of nature of study and sign an informed consent form

Exclusion Criteria

a. Dementia/significantly altered mental status that will prohibit the understanding and/or giving of informed consent

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Chiung Ing Wong, MRCP, MB ChB

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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BR03/09/04

Identifier Type: -

Identifier Source: org_study_id