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Open Access 01-12-2024 | Rectal Cancer | Study protocol

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

Authors: Hyeung-min Park, Jaram Lee, Soo Young Lee, Chang Hyun Kim, Hyeong Rok Kim

Published in: Trials | Issue 1/2024

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Abstract

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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Metadata
Title
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
Authors
Hyeung-min Park
Jaram Lee
Soo Young Lee
Chang Hyun Kim
Hyeong Rok Kim
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-08624-6

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