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Chemotherapy-Induced Cognitive Impairment: A Novel Prospective Study of the Cognitive Effects of Platinum Taxane-Based Chemotherapy in Ovarian Cancer Patients
Technical Report,01 Sep 2015,31 Aug 2016
University of Kentucky Lexington United States
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Chemotherapy-induced cognitive impairment CICI is a spectrum of neurocognitive deficits experienced during and after chemotherapy for cancer. Astherapeutic options for cancer improves, so to does survival. With more patients living longer after cancer treatments, the number of patients with these cognitive complaints is increasing and quite significant. Hypothesis At least 30 of patients undergoing platinumtaxane-based chemotherapy for ovarian cancer will experience CICI. Primary Objective To quantify cognitive changes in patients with ovarian cancer undergoing platinumtaxane chemotherapy. Secondary Objectives 1 To assess the correlation between biologic markers of oxidative stress and neurocognitive test results 2 To assess the correlation between brain imaging and neurocognitive test results. Exploratory Objectives 1 To identify the cognitive domains most affected in CICI 2 To develop a screening tool for CICI. Study Design This is a prospective, phase II study, quantifying cognitive changes in patients with ovarian cancer undergoing platinumtaxane chemotherapy. Cognitive changes will be defined by significant reliable change index RCI Z0.975 calculated between pre- and post-chemotherapy neurocognitive measurements for the MoCA total score. Patients will undergo testing prior to, and after 6 cycles of chemotherapy. Testing includes neurocognitive assessments, serum markers of oxidative stress tumor necrosis factor alpha, protein carbonyls, 4-hydroxynonenal proteins, and neuroimaging cognitive event related potentials, functional magnetic resonance imaging. Cancer Relevance The investigators of this innovative trial hope to generate new data on neurocognitive testing for CICI in gynecologic cancers, provide validation for counseling gynecologic oncology patients, and offer insight for prevention or future therapeutic interventions for CICI. During the past year, a total of 7 subjects have been enrolled.
APPROVED FOR PUBLIC RELEASE