Evidence map›Paper›PMID 39548553›Full record

ArticleTrials2024

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.

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

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Hyeung-Min ParkDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-Ro Hwasun-Eup, Hwasun-Gun, Jeonnam, 58128, Republic of Korea.
Jaram LeeDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-Ro Hwasun-Eup, Hwasun-Gun, Jeonnam, 58128, Republic of Korea.
Soo Young Lee *Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-Ro Hwasun-Eup, Hwasun-Gun, Jeonnam, 58128, Republic of Korea. syleecrs@gmail.com.ORCID http://orcid.org/0000-0002-9200-7933
Chang Hyun Kim *Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-Ro Hwasun-Eup, Hwasun-Gun, Jeonnam, 58128, Republic of Korea. cksantiago8@gmail.com.
Hyeong Rok KimDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-Ro Hwasun-Eup, Hwasun-Gun, Jeonnam, 58128, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNumerous 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.

methodsThis 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 registrationClinical Research Information Service (CRIS) of Republic of Korea, KCT0009260, Registered on March 21, 2024.

Indexed as

Administration, IntravenousAnemia, Iron-DeficiencyHemoglobinsNeoadjuvant TherapyRandomized Controlled Trials as TopicRectal NeoplasmsAdministration, OralAdultAgedChemoradiotherapy, AdjuvantDietary SupplementsEquivalence Trials as TopicFemaleHumansIronMaleHemoglobinsIronChemoradiotherapyIron-deficiency anemiaIron supplementationRectal neoplasms

Identifiers

PMID39548553
PMCPMC11566736

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.