静脉补铁与口服补铁用于接受新辅助放化疗的直肠癌患者缺铁性贫血：一项随机对照试验的研究方案。
Intravenous versus oral iron supplementation for iron deficiency anemia in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy: a study protocol for a randomized controlled trial.
机构信息
Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-Ro Hwasun-Eup, Hwasun-Gun, Jeonnam, 58128, Republic of Korea.
出版信息
Trials. 2024 Nov 15;25(1):771. doi: 10.1186/s13063-024-08624-6.
BACKGROUND
Numerous studies have been conducted to manage anemia in surgical patients through iron supplementation as an alternative to blood transfusion. However, patients with locally advanced rectal cancer have often been excluded from these studies, due to their standard treatment involving neoadjuvant chemoradiotherapy. This study aims to evaluate the impact of intravenous versus oral iron supplementation on iron deficiency anemia in patients with rectal cancer receiving preoperative chemoradiotherapy.
METHODS
This open-label, single-center, parallel, superiority, randomized trial includes patients with primary rectal cancer who are candidates for preoperative chemoradiotherapy and have confirmed iron-deficiency anemia. A total of 94 patients will be randomly assigned in a 1:1 ratio to receive either intravenous or oral iron supplementation. Stratification factors include age (> 70 vs. ≤ 70 years) and baseline serum hemoglobin levels (7-10 g/dL vs. 10-13 g/dL). The primary endpoint is the percentage of patients achieving normalized hemoglobin levels from the start of treatment to the day of admission for surgery. Secondary endpoints include changes in serum hemoglobin from baseline to postoperatively, changes in iron assay parameters, time needed to hemoglobin normalization, volume of blood transfusions required, and incidence of postoperative complications.
DISCUSSION
This study is the first randomized controlled trial investigating the effect of iron supplementation in iron-deficient patients with rectal cancer undergoing neoadjuvant chemoradiotherapy. This trial is expected to provide evidence for the benefits of administering iron supplementation in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy.
TRIAL REGISTRATION
Clinical Research Information Service (CRIS) of Republic of Korea, KCT0009260, Registered on March 21, 2024.
背景
许多研究已经通过补铁作为输血替代方法来管理手术患者的贫血。然而，由于局部晚期直肠癌患者的标准治疗包括新辅助放化疗，因此这些研究通常将其排除在外。本研究旨在评估静脉与口服补铁对接受术前放化疗的直肠癌患者缺铁性贫血的影响。
方法
这是一项开放标签、单中心、平行、优效性、随机临床试验，纳入了接受术前放化疗且已确诊缺铁性贫血的原发性直肠癌患者。共有 94 名患者将按照 1:1 的比例随机分配接受静脉或口服补铁治疗。分层因素包括年龄（>70 岁与≤70 岁）和基线血清血红蛋白水平（7-10 g/dL 与 10-13 g/dL）。主要终点是从治疗开始到手术入院时达到血红蛋白正常化的患者比例。次要终点包括从基线到术后血清血红蛋白的变化、铁检测参数的变化、血红蛋白正常化所需的时间、所需的输血量以及术后并发症的发生率。
讨论
本研究是第一项调查新辅助放化疗的直肠癌缺铁患者补铁效果的随机对照试验。本试验有望为新辅助放化疗的直肠癌患者补铁提供获益证据。
试验注册
韩国临床试验注册中心，KCT0009260，于 2024 年 3 月 21 日注册。
Zotero 插件