目的:我们评估了Nuvastatic™(C5OSEW5050ESA)在改善癌症患者癌症相关性疲劳(CRF)方面的有效性和安全性。
方法:这项多中心随机双盲安慰剂对照2期试验包括110名接受化疗的实体恶性肿瘤患者(II-IV期)。随机选择他们并每天三次口服Nuvastatic™1000mg(N=56)或安慰剂(N=54),持续9周。主要结果是在基线和第3、6和9周干预前后测量的疲劳(简短疲劳量表(BFI))和疲劳视觉模拟量表(VAS-F)评分。次要结局是医学结果量表ShortForm-36(SF-36)活力分量表的平均组间差异和尿F2-异前列腺素浓度(一种氧化应激生物标志物),东部肿瘤协作组得分,不良事件,生化和血液学参数。通过意向治疗(ITT)进行分析。通过双向重复测量方差分析(混合方差分析)评估主要和次要结果。
结果:与安慰剂组相比,Nuvastatic™组表现出总体降低的疲劳评分。与安慰剂组相比,Nuvastatic™组显着降低了BFI-疲劳(BFI疲劳评分,F(1.4,147)=16.554,p<0.001,部分η2=0.333)。Nuvastatic™组显着降低了VAS-F疲劳(F(2,210)=9.534,p<0.001,部分η2=0.083),改善生活质量(QoL)(F(1.2,127.48)=34.07,p<0.001,部分η2=0.243),和降低尿F2-IsoP浓度(平均差异(95%CI)=55.57(24.84,86.30)),t(55)=3.624,p<0.001,科恩d(95%CI)=0.48(0.20,0.75))。报告的不良事件为呕吐(0.9%),发烧(5.4%),头痛(2.7%)。
结论:Nuvastatic™可能是实体瘤患者CRF治疗的有效辅助治疗方法,值得在更大的试验中进一步研究。
背景:ClinicalTrial.govID:NCT04546607。研究注册日期(首次提交):2020年11月5日。
OBJECTIVE: We evaluated the efficacy and safety of Nuvastatic™ (C5OSEW5050ESA) in improving cancer-related fatigue (CRF) among cancer patients.
METHODS: This multicenter randomized double-blind placebo-controlled phase 2
trial included 110 solid malignant tumor patients (stage II-IV) undergoing chemotherapy. They were randomly selected and provided oral Nuvastatic™ 1000 mg (N = 56) or placebo (N = 54) thrice daily for 9 weeks. The primary outcomes were fatigue (Brief Fatigue Inventory (BFI)) and Visual Analog Scale for Fatigue (VAS-F)) scores measured before and after intervention at baseline and weeks 3, 6, and 9. The secondary outcomes were mean group difference in the vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36) and urinary F2-isoprostane concentration (an oxidative stress biomarker), Eastern Cooperative Oncology Group scores, adverse events, and biochemical and hematologic parameters. Analysis was performed by intention-to-treat (ITT). Primary and secondary outcomes were assessed by two-way repeated-measures analysis of variance (mixed ANOVA).
RESULTS: The Nuvastatic™ group exhibited an overall decreased fatigue score compared with the placebo group. Compared with the placebo group, the Nuvastatic™ group significantly reduced BFI-fatigue (BFI fatigue score, F (1.4, 147) = 16.554, p < 0.001, partial η2 = 0.333). The Nuvastatic™ group significantly reduced VAS-F fatigue (F (2, 210) = 9.534, p < 0.001, partial η2 = 0.083), improved quality of life (QoL) (F (1.2, 127.48) = 34.07, p < 0.001, partial η2 = 0.243), and lowered urinary F2-IsoP concentrations (mean difference (95% CI) = 55.57 (24.84, 86.30)), t (55) = 3.624, p < 0.001, Cohen\'s d (95% CI) = 0.48 (0.20, 0.75)). Reported adverse events were vomiting (0.9%), fever (5.4%), and headache (2.7%).
CONCLUSIONS: Nuvastatic™ is potentially an effective adjuvant for CRF management in solid tumor patients and worthy of further investigation in larger trials.
BACKGROUND: ClinicalTrial.gov ID: NCT04546607.
Study registration date (first submitted): 11-05-2020.