National Institute for Health Research Biomedical Research Centre in Gastrointestinal and Liver Diseases, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Department of Colorectal Surgery, Nottingham University Hospitals NHS Trust, University of Nottingham, Nottingham, UK.
Palliat Med. 2023 Mar;37(3):372-383. doi: 10.1177/02692163221145604. Epub 2023 Jan 6.
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).
SETTING/PARTICIPANTS: 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.
晚期癌症患者贫血的发病率很高，但缺乏足够有效和安全的治疗方法。口服铁剂耐受性差，输血仅提供短暂的益处。静脉铁已显示出作为贫血有效治疗方法的潜力，但缺乏其在晚期姑息治疗癌症患者中应用的证据。
根据筛查、招募和失访率评估试验设计的可行性。评估静脉铁（ferric derisomaltose，Monofer）治疗接受姑息治疗的实体瘤患者贫血的疗效。
一项多中心、随机、双盲、安慰剂对照的静脉铁（ferric derisomaltose，Monofer）治疗试验。结局包括试验可行性、血液指标变化以及通过三个经过验证的问卷（EQ5D5L、QLQC30 和 FACIT-F）在 8 周内评估生活质量变化。（ISRCTN；13370767）。
地点/参与者：患有贫血和晚期实体瘤、体能状态 ⩽2、正在接受专科姑息治疗服务支持的疲劳患者。
在 16 个月内对 34 名参与者进行了随机分组（17 名铁剂组，17 名安慰剂组）。在符合条件的参与者中，47%的人同意参与，总研究失访率为 26%。所有参与者均成功实现了盲法。无严重不良事件。结果表明，与安慰剂相比，静脉铁可能在改善参与者的血红蛋白、铁储存和特定于疲劳的生活质量方面更有效。
根据招募和失访率，该试验是可行的。静脉铁可增加血红蛋白，与安慰剂相比，可能改善特定于疲劳的生活质量指标。需要进一步的临床试验来确认。
