Duke University Medical Center, Durham, NC, USA.
BMC Cancer. 2010 Oct 6;10:531. doi: 10.1186/1471-2407-10-531.
The Exercise Intensity Trial (EXcITe) is a randomized trial to compare the efficacy of supervised moderate-intensity aerobic training to moderate to high-intensity aerobic training, relative to attention control, on aerobic capacity, physiologic mechanisms, patient-reported outcomes, and biomarkers in women with operable breast cancer following the completion of definitive adjuvant therapy.
METHODS/DESIGN: Using a single-center, randomized design, 174 postmenopausal women (58 patients/study arm) with histologically confirmed, operable breast cancer presenting to Duke University Medical Center (DUMC) will be enrolled in this trial following completion of primary therapy (including surgery, radiation therapy, and chemotherapy). After baseline assessments, eligible participants will be randomized to one of two supervised aerobic training interventions (moderate-intensity or moderate/high-intensity aerobic training) or an attention-control group (progressive stretching). The aerobic training interventions will include 150 mins.wk⁻¹ of supervised treadmill walking per week at an intensity of 60%-70% (moderate-intensity) or 60% to 100% (moderate to high-intensity) of the individually determined peak oxygen consumption (VO₂peak) between 20-45 minutes/session for 16 weeks. The progressive stretching program will be consistent with the exercise interventions in terms of program length (16 weeks), social interaction (participants will receive one-on-one instruction), and duration (20-45 mins/session). The primary study endpoint is VO₂peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO₂peak, patient-reported outcomes, and biomarkers associated with breast cancer recurrence/mortality. All endpoints will be assessed at baseline and after the intervention (16 weeks).
EXCITE is designed to investigate the intensity of aerobic training required to induce optimal improvements in VO₂peak and other pertinent outcomes in women who have completed definitive adjuvant therapy for operable breast cancer. Overall, this trial will inform and refine exercise guidelines to optimize recovery in breast and other cancer survivors following the completion of primary cytotoxic therapy.
NCT01186367.
EXcITe 试验是一项随机试验，旨在比较监督下中等强度有氧运动与中高强度有氧运动的疗效，相对于对照组（注意力控制组），对有氧能力、生理机制、患者报告的结果和生物标志物的影响，以评估其在接受辅助治疗后完成的可手术乳腺癌女性中的作用。
方法/设计：采用单中心、随机设计，174 名绝经后女性（58 名患者/研究组），经组织学证实为可手术乳腺癌，在杜克大学医学中心（DUMC）就诊，完成主要治疗（包括手术、放疗和化疗）后将被纳入该试验。在基线评估后，符合条件的参与者将被随机分配到两种监督下的有氧运动干预（中等强度或中高强度有氧运动）或注意力对照组（渐进式伸展）。有氧运动干预包括每周 150 分钟，每周 5 次监督下的跑步机行走，强度为 60%-70%（中等强度）或 60%-100%（中高强度）个体确定的峰值耗氧量（VO₂peak），每次 20-45 分钟/次，持续 16 周。渐进式伸展方案在方案长度（16 周）、社交互动（参与者将接受一对一指导）和持续时间（20-45 分钟/次）方面与运动干预一致。主要研究终点是通过增量心肺运动试验测量的 VO₂peak。次要终点包括控制 VO₂peak 的生理决定因素、患者报告的结果和与乳腺癌复发/死亡率相关的生物标志物。所有终点将在基线和干预后（16 周）进行评估。
EXcITe 旨在研究有氧运动的强度，以诱导接受辅助治疗后完成的可手术乳腺癌女性的 VO₂peak 和其他相关结果的最佳改善。总体而言，该试验将为优化原发性细胞毒性治疗后乳腺癌和其他癌症幸存者的恢复提供信息和完善运动指南。
NCT01186367。
