Intravenous iron tested in colorectal cancer patients with iron deficiency before surgery
Tests intravenous iron in adults with colorectal cancer and iron deficiency, without anemia.
Plain-language title generated from the registry record
Registry title: Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer
Key facts
- Where
- Køge, Randers, and Slagelse, DenmarkSee the 3 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colon or rectal cancer who have low iron but are not anaemic, before planned cancer surgery.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Colon or rectal cancer, UICC stage I-III at diagnosis, planned for elective surgery meant to remove all of the cancer.
- Earlier treatment
- No chemotherapy or radiation before surgery (neoadjuvant therapy).
- Biomarker or test result
- Haemoglobin above 7.0 mmol/L, and serum ferritin below 101 microgram/L or transferrin saturation below 21%.
Main reasons for not taking part
- Chronic kidney failure needing dialysis
- A second cancer diagnosed at a different time
- Pregnancy
- Known allergy to Iron(III)isomaltoside
- Conditions that rule out intravenous iron, such as liver cirrhosis, active hepatitis or haemochromatosis
Read by machine on 9 November 2026.
Where in Denmark
- Zealand University HospitalKøge, DenmarkNo longer taking part
- Regionshospitalet RandersRanders, DenmarkNo longer taking part
- Slagelse HospitalSlagelse, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zealand University Hospital
- Trial code
- NCT05220800
- Record updated
- 3 March 2022
- Original description
This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study.Read full original descriptionShow less
Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer: A Double Blinded Clinical Randomized Trial
This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study.
Study outline:
After initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. Then at the closest possible time to the surgery the patient will have drawn bloodwork and be re-tested by (CPET). The patient will be followed after surgery with evaluation of several outcomes including quality of recovery and complications. Further, the effects of the intervention on the patients immune function will be evaluated by two different methods: 1) by changes in neutrophil-to-lymphocyte ratio between baseline and preoperative bloodwork and 2) by evaluation mRNA expression in the tumor specimen by the Nanostring pancancer immune panel
Inclusion: Planned for curative intended elective colon or rectum cancer surgery; UICC stage I-III (at diagnosis); Hemoglobin > 7.0 mmol/L; Serum ferritin <101 microgram/L or transferrin saturation <21%.
Exclusion: Concurrent severe active bacterial infection; Neoadjuvant chemo or radiation therapy; Chronic kidney failure with need for dialysis; Metachronous diagnosed cancer; Cognitive impairment e.g. moderate to severe dementia; Known allergy for Iron(III)isomaltoside; Contraindications for intravenous iron (Pofryria, livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis); Unable to speak or understand Danish; Withdrawal of informed consent; Pregnancy.