Cognitive function in breast cancer and lymphoma patients receiving chemotherapy: An ongoing nationwide University of Rochester Cancer Center (URCC) Community Clinical Oncology Program (CCOP) observational study with 1,200 patients and controls.

Abstract

TPS9647 Background: Chemotherapy-related cognitive impairment (CRCI) is a major concern for up to 75% of cancer patients that can negatively affect quality of life. Studies which have objectively assessed cognitive function (CF) in patients suggest that chemotherapy is associated with declines in multiple domains. A large, prospective longitudinal study with age- and gender- paired healthy controls is needed to confirm and expand these findings, to identify etiological mechanisms of CRCI, and to identify the best assessment methods for detecting CRCI. Methods: We are conducting a nationwide prospective observational study (N=1,200), conducted through the URCC CCOP Research Base and 23 CCOPs. The primary aim is to test the hypothesis that breast cancer and lymphoma patients receiving chemotherapy will have greater impairments in CRCI over time than a control comparison group. Breast cancer (stage I-IIIc) and lymphoma patients (intermediate/high grade disease) meet the following eligibility: 1) chemotherapy naïve, 2) ≥21 years of age, 3) no CNS disease, 4) scheduled to receive a standard course of chemotherapy, and 5) no concurrent radiation. Healthy control participants meet eligibility criteria 1-3 and are the same gender and age as paired patients. CF is assessed at pre-chemotherapy (Assess. 1), post-chemotherapy (Assess. 2), and 6 months post-chemotherapy in patients; their paired controls are assessed at the same time intervals. CF is measured via: 1) Computer-based CANTAB neuropsychological (NP) battery (assessing memory (primary aim), verbal memory, sustained attention, processing speed, and executive function (secondary aims)), 2) paper-based objective NP assessment (secondary aims), 3) phone-based objective NP assessment (tertiary aims), and 4) Single item, patient-reported CF (tertiary aims). Blood is collected at Assess. 1 and 2 to explore inflammatory and genetic mechanisms. 807 participants have been enrolled in 21 months. Funding: U10CA037420-26 Supp. MCJ; U10CA037420, GRM; & URCC/RPCI Grant, MCJ & CBA. Clinical trial information: NCT01382082.