接受新辅助放化疗的直肠癌患者缺铁性贫血的静脉注射与口服补铁疗法：随机对照试验的研究方案。

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Trials Pub Date : 2024-11-15 DOI:10.1186/s13063-024-08624-6

Hyeung-Min Park, Jaram Lee, Soo Young Lee, Chang Hyun Kim, Hyeong Rok Kim

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引用次数: 0

摘要

背景：已有大量研究通过补充铁剂替代输血来治疗手术患者的贫血。然而，局部晚期直肠癌患者往往被排除在这些研究之外，因为他们的标准治疗包括新辅助化放疗。本研究旨在评估静脉补铁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：这项开放标签、单中心、平行、优势、随机试验的研究对象包括原发性直肠癌患者，这些患者都是术前化疗的候选者，并已证实患有缺铁性贫血。共有 94 名患者将按 1:1 的比例随机分配接受静脉或口服铁剂补充。分层因素包括年龄（大于 70 岁 vs. 小于 70 岁）和基线血清血红蛋白水平（7-10 克/分升 vs. 10-13 克/分升）。主要终点为从治疗开始到入院手术当天血红蛋白水平达到正常的患者比例。次要终点包括血清血红蛋白从基线到术后的变化、铁测定参数的变化、血红蛋白恢复正常所需时间、所需输血量以及术后并发症的发生率：本研究是第一项随机对照试验，调查了对接受新辅助放化疗的缺铁直肠癌患者补充铁剂的效果。该试验有望为接受新辅助放化疗的直肠癌患者补充铁剂的益处提供证据：试验注册：大韩民国临床研究信息服务（CRIS），KCT0009260，注册日期：2024年3月21日。

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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.

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.

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.