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

卵巢癌女性运动和生活方式试验 (TEAL)

• 批准号: 10626041
• 负责人: Tracy E Crane
• 金额: $ 117.56万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-23 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10626041
• 关键词: Acceleration; Address; Aftercare; Arthralgia; Attenuated; Behavior; Biological Markers; Black Populations; Body Composition; Cancer Patient; Cancer Survivor; Creatine; Diagnosis; Diet; Dietary Intervention; Disease; Disease-Free Survival; Disparity; Dose; Enrollment; Ethnic Origin; Exercise; Fatigue; Gynecologic Oncology Group; Healthcare; Hispanic Populations; Home; Image; Impaired cognition; Intervention; Life Style; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of ovary; Measures; Medical Nutrition Therapy; Mental Depression; Methods; Muscular Atrophy; Neuropathy; Newly Diagnosed; Not Hispanic or Latino; Obesity; Operative Surgical Procedures; Outcome; Patients; Physical activity; Platinum; Quality of life; Race; Randomized; Randomized, Controlled Trials; Reporting; Research; Resources; Sample Size; Sampling; Site; Stage at Diagnosis; Survival Rate; Testing; Time; Toxic effect; Toxicity due to chemotherapy; Visit; Walking; Woman; Work; X-Ray Computed Tomography; aggressive therapy; arm; attentional control; behavior change; cancer survival; chemotherapy; cognitive function; common treatment; comorbidity; diet and exercise; dosage; ethnic disparity; ethnic diversity; exercise intervention; experience; feasibility trial; follow-up; gastrointestinal; health care service utilization; healthy lifestyle; improved; intervention effect; lifestyle intervention; malignant breast neoplasm; mortality; muscle form; nutrition; post intervention; primary endpoint; racial disparity; racial diversity; randomized trial; sarcopenia; standard of care; taxane; treatment optimization; urinary

Project Abstract/Summary Ovarian cancer (OC) is the most lethal gynecologic malignancy, with disparities in survival by race and ethnicity. Nearly all stages of OC require aggressive treatment, such that 90% of women diagnosed receive chemotherapy. First-line treatment includes surgery and six cycles of platinum- and taxane-based chemotherapy. Timely and successful completion of chemotherapy is critical, as delayed or reduced chemotherapy dosage for OC is associated with decreased survival; yet 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 interventions in women with OC and relevant 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 multi-site randomized trial of an 18-week medical nutrition therapy and exercise intervention vs. attention control in a racially and ethnically diverse sample of 200 women newly diagnosed with OC (stage I-IV) and initiating curative intent chemotherapy to assess the effect of the intervention on: 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 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.

项目摘要/总结 卵巢癌 (OC) 是最致命的妇科恶性肿瘤，不同种族和不同种族的生存率存在差异 几乎所有 OC 阶段都需要积极治疗，90% 的诊断女性都接受了积极治疗。 一线治疗包括手术和六个周期的铂类和紫杉烷类药物。 化疗的及时和成功完成至关重要，因为化疗会延迟或减少。 OC 的化疗剂量与生存率降低相关；然而化疗剂量延迟和剂量 剂量延迟和减少的主要原因是化学毒性，包括。 神经病变、认知功能障碍、疲劳、抑郁、关节痛和胃肠道毒性。 患有 OC 的女性接受化疗的另一个后果是控制化学毒性。 营养和运动。我们的团队在领导多地点营养和运动方面拥有丰富的经验。 对 OC 女性的干预措施以及专门针对化疗的试验的相关经验 我们将利用这些专业知识来解决一个关键差距：如何减少化学毒性和 我们建议进行一项为期 18 周的多中心随机试验。 医学营养治疗和运动干预与种族和民族多元化的注意力控制 对 200 名新诊断为 OC（I-IV 期）并开始治疗性化疗的女性进行了抽样调查 评估干预措施对以下方面的影响： 目标 1：相对剂量强度 (RDI)，一种综合衡量指标 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； 通过 CT 扫描和尿 D3-肌酸稀释法评估肌肉质量；目标 4：长期； 生活方式行为、身体成分、患者报告的化学毒性和医疗保健利用评估 3- 我们欺负了随机接受干预的女性。 与注意力控制组中的女性相比，由于患者报告的数量较少，RDI 会更高 与注意力相比，干预将导致身体成分的下降减弱。 反过来，随机接受干预的女性将长期保持健康的生活方式 对挥之不去的化学毒性和身体成分产生有利影响，导致医疗保健利用率降低 与注意力控制相比，我们的方法的优点是基线、随访和干预。 持续时间按照护理标准安排，一线化疗在约 18 周时完成（当我们 主要终点将被评估），女性在这个时间点接受重复成像评估，并且 3 个月后，积极的结果将加速 OC 患者接受营养和治疗的模式转变。 将运动计划作为护理标准与化疗治疗相结合，以尽量减少化疗毒性 并优化治疗剂量以达到治疗效果。