一项随机对照试验比较了在开始接受恩扎卢胺和雄激素剥夺治疗的非转移性去势敏感前列腺癌（EXTEND）患者中，有监督运动与无监督运动对体能变化的影响。
A randomized controlled trial comparing changes in fitness with or without supervised exercise in patients initiated on enzalutamide and androgen deprivation therapy for non-metastatic castration-sensitive prostate cancer (EXTEND).
机构信息
Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University Medical Center, Durham, NC, USA.
Department of Kinesiology, UNC-Greensboro, Greensboro, NC, USA.
出版信息
Prostate Cancer Prostatic Dis. 2022 Mar;25(1):58-64. doi: 10.1038/s41391-022-00519-4. Epub 2022 Mar 10.
BACKGROUND
Androgen deprivation therapy (ADT) and androgen receptor signaling inhibitors (ARSI) are associated with deleterious physical effects, which exercise may mitigate; however, exercise has never been studied in patients initiating treatment with ADT and an ARSI. Our objective was to determine whether supervised exercise prior to and during initial therapy could mitigate adverse effects of ADT plus enzalutamide.
METHODS
We conducted a single center trial in patients with recurrent prostate cancer treated with ADT and enzalutamide. We randomized 26 patients to 16 weeks of supervised exercise (aerobic and resistance), starting 4 weeks before initiation of ADT and enzalutamide, or usual care. The primary endpoint was change in peak oxygen uptake (VOpeak) as a measure of cardiorespiratory fitness (CRF). Secondary endpoints were functional capacity, maximal strength, body composition, patient-reported outcomes, safety, and feasibility. Analysis of covariance was used to compare outcomes for groups at Week 17 adjusted for baseline values.
RESULTS
The usual care group (N = 13) showed declines from baseline to week 17 in both absolute CRF (-0.31 L/min, -10.9%; p < 0.01) and relative CRF (-3.2 mL/kg/min, -8.9%; p = 0.04); worse fatigue (p = 0.01); and worse quality of life (p = 0.01). At week 17, the exercise group (N = 13) demonstrated improved absolute CRF (between-group change +0.20 L/min, p = 0.05), leg strength (+48.6 kg, p < 0.01) and functional capacity (+21.0 m, p = 0.01) at week 17.
CONCLUSIONS
This is the first randomized controlled trial demonstrating a clinically significant decline in CRF in patients initiating ADT and enzalutamide. We show the effectiveness of short-term supervised exercise to mitigate declines in absolute CRF, and improve maximal leg strength and functional capacity.
GOV IDENTIFIER
NCT02256111.
背景
雄激素剥夺疗法（ADT）和雄激素受体信号抑制剂（ARSI）与有害的身体影响有关，而运动可能会减轻这些影响；然而，在开始 ADT 和 ARSI 治疗的患者中，运动从未被研究过。我们的目的是确定在开始 ADT 加恩扎卢胺治疗之前和期间进行监督下的锻炼是否可以减轻 ADT 的不良反应。
方法
我们在接受 ADT 和恩扎卢胺治疗的复发性前列腺癌患者中进行了一项单中心试验。我们将 26 名患者随机分为 16 周的监督锻炼（有氧运动和阻力运动）组，该组从开始 ADT 和恩扎卢胺前 4 周开始，或常规护理组。主要终点是峰值摄氧量（VOpeak）的变化，作为心肺功能（CRF）的衡量标准。次要终点是功能能力、最大力量、身体成分、患者报告的结果、安全性和可行性。使用协方差分析比较 17 周时两组的结果，调整基线值。
结果
常规护理组（n=13）在绝对 CRF（-0.31 L/min，-10.9%；p<0.01）和相对 CRF（-3.2 mL/kg/min，-8.9%；p=0.04）均从基线下降到第 17 周；疲劳更严重（p=0.01）；生活质量更差（p=0.01）。在第 17 周，锻炼组（n=13）在第 17 周时显示出绝对 CRF（组间变化+0.20 L/min，p=0.05）、腿部力量（+48.6 kg，p<0.01）和功能能力（+21.0 m，p=0.01）的改善。
结论
这是第一项随机对照试验，表明开始 ADT 和恩扎卢胺治疗的患者的 CRF 出现了临床显著下降。我们证明了短期监督锻炼可以减轻绝对 CRF 的下降，并改善最大腿部力量和功能能力。
政府标识符
NCT02256111
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