BECKMAN RESEARCH INSTITUTE OF THE CITY OF HOPE
Grant: $182,598 - National Institutes of Health - May. 18, 2009
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Award Description: Pro-inflammatory cytokines and neurobehavioral symptoms in women with breast cancer. Abstract Survivors of breast cancer report debilitating behavioral symptoms, such as fatigue and neurocognitive dysfunction, which are evident in some individuals even at pre-treatment baseline. There is sufficient evidence from varied lines of research to propose that cancer-related neurobehavioral symptoms may be driven, at least in part, by activation of the pro-inflammatory cytokine network. Concentrations of specific pro-inflammatory cytokines (IL-6, TNF) and soluble receptors in serum obtained prior to treatment in breast cancer patients are significantly higher than levels found in healthy individuals and have prognostic value; however, these pre- treatment elevations have not yet been evaluated with respect to their association with either acute or chronic behavioral symptoms. Among survivors of breast cancer, elevated levels of circulating sIL-6R and IL-1ra have emerged as prominent biomarkers of persistent fatigue in cross-sectional studies of women several years post chemotherapy. No similar work has identified biomarkers of neurocognitive dysfunction in this patient population, and it is not known if the cytokine links with fatigue, or other behavioral symptoms, exist closer to the diagnosis period or evolve over time as 'late effects'. In this study, we will address this knowledge gap as we will evaluate this association prior to cancer treatment, and again following treatment completion. We will compare these associations in a minimum of 137 breast cancer patients relative to two comparison groups at pre-treatment, and longitudinally evaluate only the breast cancer group after treatment. Findings are expected to increase our knowledge about the possible biomarkers associated with neurobehavioral symptoms in breast cancer patients, for the purpose of better identifying and treating those at risk for such effects. PUBLIC HEALTH RELEVANCE: Findings are expected to increase knowledge about the possible biomarkers associated with neurobehavioral symptoms in breast cancer patients, for the purpose of better identifying and treating those at risk for such effects.
Project Description: Progress on this study has included recruitment and hiring of personnel, developing the necessary systems and lines of communication to conduct the study, and training research staff in study procedures. Training has included how to explain the study to eligible patients, how to conduct the study assessments, how to identify individuals that have elevated distress levels and may require referrals for treatment services, etc, and other such issues relevant for ethical conduct of research with human subjects. Identification and recruitment of eligible participants has been initiated and the study is underway.
Jobs Summary: Principal Investigator (PI) has the primary responsibility of overseeing the overall organization and scientific conduct of the study. PI specific responsibilities include study management including training and leadership of project staff, piloting all recruitment and data management procedures, regular communication with the project staff and research team, quality control, supervision of data collection, data management, and analysis. Project Coordinator assists the PI in ensuring an efficient and timely conduct of the study, especially in terms of patient identification and recruitment, data collection, database development, and coordinating the neurocognitive testing and blood draws at pre-determined time-points. She is responsible for explaining the study to the study participants, and also for the smooth and efficient conduct of the study assessments. (Total jobs reported: 0)
Project Status: Less Than 50% Completed
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