ICaRAS随机对照试验:静脉铁治疗晚期癌症患者贫血的招募、干预和提供的可行性。
The ICaRAS randomised controlled trial: Intravenous iron to treat anaemia in people with advanced cancer - feasibility of recruitment, intervention and delivery.
发表日期:2023 Jan 06
作者:
Edward A Dickson, Oliver Ng, Barrie D Keeler, Andrew Wilcock, Matthew J Brookes, Austin G Acheson
来源:
PALLIATIVE MEDICINE
摘要:
贫血在晚期和姑息治疗的癌症患者中极为普遍,但缺乏有效且安全的治疗方法。口服铁质不耐受,输血只能提供短暂的好处。静脉注射铁剂显示出作为治疗贫血的有效方法的希望,但在晚期和姑息治疗的癌症患者中的使用缺乏证据。评估试验设计的可行性,包括筛查、招募和退群率。评估静脉注射铁剂治疗实体瘤患者贫血的疗效。多中心、随机、双盲、安慰剂对照试验,采用静脉注射铁剂(双羟甲基丙烯酸铁,Monofer®)。结果包括试验可行性、血液指标变化以及通过三个经过验证的问卷(EQ5D5L、QLQC30和FACIT-F)评估生活质量的变化。测试时间为8周(ISRCTN;13370767)。测试对象为接受专业姑息治疗并具有表现状态≤2的贫血和实体瘤患者。16个月内共有34名参与者随机分配(17个注射铁剂,17个安慰剂)。在符合条件的人群中,有47%的人同意参加,总体研究退群率为26%。所有参与者都保持双盲状态。没有发生严重的不良反应。结果表明,与安慰剂相比,静脉注射铁剂可能有效地改善参与者的血红蛋白、铁储存和特定疲劳生活质量测量的结果。根据招募和退群率,该试验的可行性得到证明。静脉注射铁剂可以增加血红蛋白,并可能改善疲劳特定的生活质量测量指标。需要进行明确的试验以确认这一结果。
Anaemia is highly prevalent in people with advanced, palliative cancer yet sufficiently effective and safe treatments are lacking. Oral iron is poorly tolerated, and blood transfusion offers only transient benefits. Intravenous iron has shown promise as an effective treatment for anaemia but its use for people with advanced, palliative cancer lacks evidence.To assess feasibility of the trial design according to screening, recruitment, and attrition rates. To evaluate the efficacy of intravenous iron to treat anaemia in people with solid tumours, receiving palliative care.A multicentre, randomised, double blind, placebo-controlled trial of intravenous iron (ferric derisomaltose, Monofer®). Outcomes included trial feasibility, change in blood indices, and change in quality of life via three validated questionnaires (EQ5D5L, QLQC30, and the FACIT-F) over 8 weeks. (ISRCTN; 13370767).People with anaemia and advanced solid tumours who were fatigued with a performance status ⩽2 receiving support from a specialist palliative care service.34 participants were randomised over 16 months (17 iron, 17 placebo). Among those eligible 47% of people agreed to participate and total study attrition was 26%. Blinding was successful in all participants. There were no serious adverse reactions. Results indicated that intravenous iron may be efficacious at improving participant haemoglobin, iron stores and select fatigue specific quality of life measures compared to placebo.The trial was feasible according to recruitment and attrition rates. Intravenous iron increased haemoglobin and may improve fatigue specific quality of life measures compared to placebo. A definitive trial is required for confirmation.