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Sponsored by: |
National University Hospital, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00713141 |
Primary Objective
Secondary Objective
• To validate the use of hydrogen peroxide and serum amyloid as biomarkers of damage
Condition |
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Early Breast Cancer |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Evaluation of Brain Function Before and After Standard Chemotherapy for Early Breast Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | November 2004 |
Groups/Cohorts |
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1
Early breast cancer
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
A pilot study involving 30 women who have been diagnosed with breast cancer and will undergo standard adjuvant chemotherapy will be conducted first. This is to allow (1) the establishment of the acceptability of the procedure to patients and (2) documentation of the various effect sizes associated with (a) cognitive changes (b) changes in the level of the various biochemical markers following chemotherapy (c) the relationship between extent of cognitive decline and extent of DNA damage. It is estimated that up to approximately 100 patients can be recruited to participate in the main study.
Inclusion Criteria:
Exclusion criteria
a. Dementia/significantly altered mental status that will prohibit the understanding and/or giving of informed consent
Contact: Chiung Ing Wong, MRCP, MB ChB | 65-6772-1852 | Chiung_Ing_Wong@nuh.com.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore | |
Contact: Chiung Ing Wong, MRCP, MB ChB 65-6772-1852 Chiung_Ing_Wong@nuh.com.sg | |
Principal Investigator: Chiung Ing Wong, MRCP, MB ChB |
Principal Investigator: | Chiung Ing Wong, MRCP, MB ChB | National University Hospital, Singapore |
Study ID Numbers: | BR03/09/04 |
Study First Received: | July 10, 2008 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00713141 |
Health Authority: | Singapore: Domain Specific Review Boards |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |