Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2029-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Collaborators: Randers Regional Hospital; Slagelse Hospital

Criteria

Inclusion Criteria:

• 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 Criteria:

• Chronic kidney failure with need for dialysis

• Metachronous diagnosed cancer

• Unable to speak or understand Danish

• Cognitive impairment e.g. moderate to severe dementia

• Concurrent severe active bacterial infection

• Known allergy for Iron(III)isomaltoside

• Contraindications for intravenous iron (Pofryria, livercirrosis, active hepatitis, transaminases three times the upper limit, hemosiderosis and hemochromatosis)

• Withdrawal of informed consent

• Neoadjuvant chemo or radiation therapy

• Pregnancy