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

项目 摘要/概要 卵巢 种族 化疗 化疗 化疗 癌症（OC）是最致命的妇科恶性肿瘤，不同种族和性别的生存率存在差异， 几乎所有阶段的OC都需要积极的治疗， 一线治疗包括手术和六个周期的拉丁和紫杉烷为基础的 及时和成功地完成化疗是至关重要的， OC的剂量与生存率降低相关;然而 C 90%的确诊女性 p 化疗剂量延迟和剂量 减少是常见的。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 OC女性化疗的另一个后果。管理化学毒性的策略包括 营养和锻炼。我们的团队在领导多站点营养和运动方面拥有丰富的经验 OC女性患者的干预措施和专门针对化疗的试验的相关经验 完成率。我们将利用这些专业知识来解决一个关键的差距：如何减少化学毒性， OC妇女的治疗延迟。我们建议进行一项 医疗 样品 评估目标1：相对剂量强度（RDI）， 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、关节痛和胃肠道紊乱;目标3：身体成分 一项为期18周的多中心随机试验 营养治疗和运动干预与注意力控制在一个种族和民族多样化的 00名新诊断为OC（I-IV期）并开始治疗性化疗的女性， 干预对以下方面的影响： 2 通过CT扫描和尿D3评估肌肉质量 - 肌酸 目标4：长期 生活方式行为、身体组成、患者报告的化疗毒性和医疗保健利用评估3- 干预后12个月和诊断后12个月。我们假设随机接受干预的女性 与注意力控制组的女性相比， 化学毒性与注意力相比，干预将导致身体成分的衰减下降 对照组，随机分配到干预组的妇女将长期保持健康的生活方式， 有利地影响持续的化学毒性和身体组成，导致较少的医疗保健利用 与注意力控制相比。我们方法的优势在于基线、随访和干预 持续时间与标准治疗时间一致，一线化疗在约18周时完成（当我们 将评估主要终点），在该时间点接受重复影像学评估的女性， 三个月后。积极的结果将加速OC患者接受营养的范式转变， 将运动规划作为标准治疗与化疗联合使用，以最大限度地减少化疗毒性 并优化治疗剂量输送以获得治愈效果。

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.