Interventions Targeting Inflammation for Chemotherapy-Related Cognitive Problems

针对化疗相关认知问题的炎症干预措施

• 批准号: 8638907
• 负责人: Michelle C Janelsins
• 金额: $ 14.49万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8638907
• 关键词: Adjuvant Chemotherapy; Adult; Aftercare; Analysis of Covariance; Anti-Inflammatory Agents; Anti-inflammatory; Area; Attention; Award; B-Lymphocytes; Basic Science; Behavioral; Behavioral Research; Biological Assay; Biometry; CCL2 gene; Cancer Control; Cancer Patient; Clinical; Clinical Research; Clinical Trials; Cognition; Cognitive; Cognitive Science; Commit; Cytokine Receptors; Data; Development; Development Plans; Disease; Education; Ensure; Environment; Etiology; Exercise; Exercise Physiology; Female Breast Carcinoma; Flow Cytometry; Foundations; Funding; Future; Goals; Health education; Home environment; Ibuprofen; Immune; Immunology; Impaired cognition; Inflammation; Inflammatory; Interleukin-1; Interleukin-10; Interleukin-6; Intervention; K-Series Research Career Programs; Knowledge; Light; Link; Malignant Neoplasms; Measurement; Measures; Mediating; Medical Oncology; Medical center; Memory; Mentors; Nerve Degeneration; Neuropsychological Tests; Neurosciences; Pathway interactions; Patient Care; Patients; Pharmaceutical Preparations; Phase; Physical activity; Pilot Projects; Placebo Control; Placebos; Positioning Attribute; Production; Public Health; Quality of life; Radiation Oncology; Randomized; Randomized Controlled Clinical Trials; Reporting; Research; Research Personnel; Resistance; Risk; Serum; TNF gene; Time; Training; Universities; Walking; Work; arm; base; cancer therapy; career; career development; cell type; chemobrain; chemotherapy; cognitive function; computerized; cytokine; design; effective therapy; executive function; experience; improved; intervention effect; malignant breast neoplasm; monocyte; neurocognitive test; neuropsychological; novel; professor; programs; public health relevance; skills; skills training; therapy development; three-arm study; visual memory

DESCRIPTION (provided by applicant): Hemotherapy-related cognitive impairment (CRCI) is a significant problem that develops in up to 75% of breast cancer patients, often persisting for many years and significantly impairing quality of life. The etiology of CRCI is not clearly understood, and there are no effective management approaches. Reduction of inflammation is a promising target to alleviate CRCI, and translational investigators well versed in clinical and behavioral research, immunology and neuroscience are needed to advance knowledge in this area. Dr. Michelle Janelsins, an Assistant Professor in the Department of Radiation Oncology at the University of Rochester Medical Center, is applying for a K07 mentored career development award to expand her clinical and behavioral research skills and to integrate new skills with her strong basic science abilities as an independent clinical and translational cancer control investigator with expertise in interventions for CRCI. This application provides Dr. Janelsins with new training and skills necessary to develop, implement, and assess interventions in a clinical setting and combine these new abilities with her established skills and knowledge in immunology and neuroscience to successfully conduct the first randomized, controlled, pilot study we are aware of investigating the influence of two novel interventions (exercise and ibuprofen) on CRCI and inflammation. Career Development Plan: Dr. Janelsins' previous training provides an outstanding initial foundation, but she needs new training in the conduct of Phase II-III clinical trials, cognitive assessment and related bio behavioral immune pathways, and exercise intervention development to become a successful independent clinical researcher with expertise in bio behavioral research focusing on understanding and alleviating CRCI. Her four career development training goals are: 1) to develop expertise in cancer control Phase II-III clinical trials, 2) to develop expertise in cognitive science and cognitive assessments and related bio behavioral immune pathways, 3) to develop expertise in exercise physiology, physical activity assessments and exercise interventions, and 4) to promote the development of an independent academic research career. Dr. Janelsins has an outstanding mentoring team: Dr. Gary Morrow, a leading cancer control researcher with NCI funding for over thirty years, is her senior mentor; Drs. Tim Ahles and Deborah Cory-Slechta provide expertise in neurocognitive testing as her co-mentors; Dr. Karen Mustian provides expertise in exercise interventions as a co-mentor; and advisors Drs. Jan Moynihan (immunology), Michelle Shayne (medical oncology), and Charles Heckler (biostatistics) provide specific expertise in key areas. Research Plan: The proposed Phase II RCT, based partially on Dr. Janelsins' preliminary data, is a three-arm study comparing the influence of ibuprofen + health education (Arm 1), placebo + exercise (Arm 2) and placebo + health education (control; Arm 3) on CRCI in 120 breast cancer patients undergoing chemotherapy experiencing CRCI. The exercise and ibuprofen arms will each be compared to the control (Arm 3) with the primary goal of assessing, analyzing, and interpreting the preliminary efficacy of each intervention in alleviating CRCI and the effects of each intervention on inflammation. This award will position Dr. Janelsins to become a leader in the cancer and cognition field who, over her career, will make meaningful contributions to patient care. Research findings will be used to design future definitive RCTs, ensure Dr. Janelsins' successful transition to an independent, R01- funded, clinical and translational investigator, and ultimately reduce the public health burden from CRCI.

描述（由申请人提供）：血液治疗相关认知障碍（CRCI）是高达75%的乳腺癌患者出现的一个重要问题，通常持续多年并显著影响生活质量。CRCI的病因尚不清楚，也没有有效的治疗方法。减少炎症是缓解CRCI的一个有希望的目标，需要精通临床和行为研究、免疫学和神经科学的转化研究人员来推进这一领域的知识。Michelle Janelsins博士是罗切斯特大学医学中心放射肿瘤系的助理教授，她正在申请K07指导职业发展奖，以扩展她的临床和行为研究技能，并将新技能与她强大的基础科学能力相结合，作为一名独立的临床和转化癌症控制研究者，她在CRCI干预方面具有专业知识。本应用程序为Janelsins博士提供