Trial of Exercise and Lifestyle (TEAL) in Women with Ovarian Cancer

项目 摘要/摘要 卵巢 种族问题。 化疗。 化疗。 化疗 癌(OC)是最致命的妇科恶性肿瘤，其存活率因种族和性别不同而不同。 几乎所有的卵巢癌阶段都需要积极的治疗，以至于 一线治疗包括手术和六个周期的拉丁和紫杉烷 及时和成功地完成化疗是至关重要的，因为延迟或减少了 OC的剂量与生存率下降有关；然而 C 90%的确诊女性接受了 P 化疗剂量延迟与剂量 减产是很常见的。剂量延迟和减少的主要原因是化学毒性，包括 神经病、认知功能障碍、疲劳、抑郁、关节痛和胃肠道毒性。肌肉损失是 化疗对患有OC的妇女的另一个后果。管理化疗毒性的策略包括 营养和锻炼。我们的团队在领导多点营养和运动方面拥有丰富的经验 卵巢癌妇女的干预和专门针对化疗的试验的相关经验 完成率。我们将利用这一专业知识来解决一个关键差距：如何降低化学毒性和 女性OC患者的治疗延迟。我们建议进行一项 医学 样本 评估目标1：相对剂量强度(RDI)，这是 化疗剂量延迟和减少；目标2：患者报告的化疗毒性，包括神经病变， 认知功能、抑郁、疲劳、关节痛和胃肠紊乱；目标3：身体成分 一项为期18周的多点随机试验 不同种族和民族的营养治疗和运动干预与注意力控制 在新诊断为OC(I-IV期)并开始治疗意向化疗的00名妇女中 干预措施对以下方面的影响： 2. 通过CT扫描和尿液D3评估肌肉质量 -肌酸 稀释法；和目标4：长期 生活方式行为、身体成分、患者报告的化疗毒性和卫生保健利用情况评估3- 干预后3个月和诊断后12个月。我们假设女性随机接受干预 与注意力控制臂中的女性相比，RDI会更高，因为报告的患者更少 化疗毒性。与注意力相比，干预将导致身体成分的减弱下降 对照，而随机接受干预的女性将长期保持健康的生活方式行为 有利地影响挥之不去的化学毒性和身体成分，导致医疗保健利用率降低 与注意力控制相比。我们方法的优点是基线、后续访问和干预 在一线化疗在~18周完成时(当我们的 将评估主要终点)，在此时间点接受重复成像评估的女性 3个月后。积极的结果将加速OC患者接受营养和治疗的范式转变 将运动规划作为化疗联合治疗的标准护理方案，将化疗毒性降至最低 并优化治疗剂量传递，以获得疗效。

Project Abstract/Summary Ovarian ethnicity. chemotherapy. chemotherapy. chemotherapy ancer (OC) is the most lethal gynecologic malignancy, with disparities in survival by race and Nearly all stages of OC require aggressive treatment, such that First-line treatment includes surgery and six cycles of latinum- and taxane-based Timely and successful completion of chemotherapy is critical, as delayed or reduced dosage for OC is associated with decreased survival; yet c 90% of women diagnosed receive p chemotherapy dose delays and dose reductions are common. The primary reason for dose delays and reductions is chemotoxicity, including neuropathy, cognitive dysfunction, fatigue, depression, arthralgia, and gastrointestinal toxicities. Muscle loss is an additional consequence of chemotherapy in women with OC. Strategies to manage chemotoxicities include nutrition and exercise. Our team has extensive experience in leading multi-site nutrition and exercise interventionsin women with OC andrelevant experience with trials specifically addressing chemotherapy completion rates. We will leverage this expertise to address a critical gap: how to reduce chemotoxicity and treatment delays in women with OC. We propose to conduct a medical sample assess Aim 1: Relative dose intensity (RDI), an integrated measure of chemotherapy dose delays and reductions; Aim 2: Patient-reported chemotoxicities including neuropathy, cognitive function, depression, fatigue, arthralgia, and gastrointestinal disturbances; Aim 3: Body composition multi-site randomized trial of an 18-week nutrition therapy and exercise intervention vs. attention control in a racially and ethnically diverse of 00 women newly diagnosed with OC (stage I-IV) and initiating curative intent chemotherapy to the effect of the intervention on: 2 and muscle mass assessed via CT scans and urinary D3 ‐ Creatine dilution method; and Aim 4: Long-term lifestyle behaviors, body composition, patient-reported chemotoxicities, and health care utilization assessed 3- months post-intervention and 12-months post-diagnosis. We hypothesize women randomized to intervention will have higher RDI as compared to women in the attention control arm because of fewer patient-reported chemotoxicities. The intervention will result in attenuated declines in body composition compared with attention control, and women randomized to the intervention will maintain healthy lifestyle behaviors long-term, in turn favorably impacting lingering chemotoxicities and body composition, resulting in less health care utilization compared with attention control. Strengths of our approach is that baseline, follow-up visits and the intervention duration are timed with standard of care in that first-line chemotherapy is completed at ~18 weeks (when our primary endpoint will be assessed) with women undergoing repeat imaging assessments at this timepoint and 3 months later. Positive results would accelerate a paradigm shift with OC patients receiving nutrition and exercise programming as standard of care in tandem with chemotherapy treatment to minimize chemotoxicity and optimize treatment dose delivery for a curative outcome.