Early Breast Cancer Clinical Trial
Official title:
Evaluation of Brain Function Before and After Standard Chemotherapy for Early Breast Cancer
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
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.
;
Observational Model: Case Control, Time Perspective: Cross-Sectional
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