Study of biomarkers in ovarian cancer: modulation by activity & diet intervention

卵巢癌生物标志物的研究：活性调节

基本信息

批准号：
9461246
负责人：
KAREN M BASEN-ENGQUIST
金额：
$ 3.58万
依托单位：
UNIVERSITY OF ARIZONA
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-08-01 至 2019-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9461246
关键词：
Adopted Aftercare Attention Behavior Therapy Behavioral Biological Biological Markers Blood specimen Cancer Advocacy Cancer Survivor Cancer Survivorship Cessation of life Cholesterol Clinical Community Clinical Oncology Program Control Groups Controlled Study Data Diet Dietary Intervention Disease Disease Progression Enrollment Funding Goals Gynecologic Oncology Group Health High Density Lipoproteins Inflammation Inflammatory Inflammatory Response Insulin Insulin Resistance Interleukin-6 Intervention Knowledge Life Style Lipids Low-Density Lipoproteins Malignant Female Reproductive System Neoplasm Malignant Neoplasms Malignant neoplasm of ovary Mediating Mesothelium Metabolic Monitor Obesity Outcome Participant Patient-Focused Outcomes Patients Physical activity Play Postdoctoral Fellow Progression-Free Survivals Protocols documentation Randomized Recurrence Recurrent disease Regulation Research Research Infrastructure Resources Risk Risk Factors Role Sampling Scanning Schedule Survivors Testing Time Translating Visceral Vulnerable Populations Woman Work X-Ray Computed Tomography arm attentional control base cancer diagnosis cancer survival design energy balance evidence base follow-up group intervention high risk improved indexing intervention effect lifestyle intervention lipid metabolism mortality novel outcome forecast programs public health relevance tumor progression

项目摘要

DESCRIPTION (provided by applicant): Ovarian cancer accounts for over 18,000 deaths each year in the U.S. with disease progression rates estimated at 60-70% after 4 years. The efficacy of a physical activity + dietary intervention to increase progression-free survival (PFS) in this vulnerable population is currently being tested in a hypothesis-driven, randomized, attention-control study of 1070 women with prior invasive disease [(Gynecological Oncology Group (GOG) 0225 study (Lifestyle Intervention for oVarian cancer Enhanced Survival- (LIVES) Trial]. Here, we propose to take advantage of the trial infrastructure and capacity to collect repeat blood samples to evaluate the mechanistic underpinnings that might explain any changes in health indices by treatment arm over time. The overarching hypothesis is that change in metabolic and inflammatory status of participants, that is expected to demonstrate a reduction in inflammation and metabolic deregulation in the intervention group participants more so than the attention-control group, will be associated with increased PFS. A secondary focus of the proposed work will be the interaction with central adiposity. The Specific Aims include: To determine if the LIVES intervention alters biomarkers of metabolic deregulation in women previously treated for stage II-IV ovarian cancer; Aim 2: To determine if any effect of the intervention on biomarkers is mediated by change in central adiposity; and Aim 3: To determine if any effect of the intervention on biomarkers is modified by baseline central adiposity including exploration of central adiposity using Computerized Tomography (CT) scans. Our longer term goal is to determine whether change in central adiposity, insulin/lipid metabolism or inflammation is associated with progression free survival.

描述（由申请人提供）：在美国，卵巢癌每年导致超过 18,000 人死亡，4 年后疾病进展率估计为 60-70%。目前正在对 1070 名既往患有侵袭性疾病的女性进行一项假设驱动、随机、注意力控制研究，测试体力活动 + 饮食干预对提高这一弱势群体无进展生存期 (PFS) 的功效 [(妇科肿瘤学组(GOG) 0225 研究（卵巢癌生活方式干预增强生存 - (LIVES) 试验]。在这里，我们建议利用试验基础设施和收集重复血液样本的能力来评估可能解释治疗组健康指数随时间变化的机制基础最主要的假设是参与者代谢和炎症状态的变化，预计这将证明干预组参与者的炎症和代谢失调的减少更多。注意力控制组将与 PFS 的增加相关，拟议工作的第二个重点是与中心性肥胖的相互作用。具体目标包括：确定 LIVES 干预是否会改变之前接受 II-IV 期卵巢癌治疗的女性代谢失调的生物标志物；目标 2：确定干预措施对生物标志物的影响是否是由中枢性肥胖的变化介导的；目标 3：确定干预措施对生物标志物的影响是否会因基线中心性肥胖而改变，包括使用计算机断层扫描 (CT) 扫描探索中心性肥胖。我们的长期目标是确定中心性肥胖、胰岛素/脂质代谢或炎症的变化是否与无进展生存期相关。