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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital

About this 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

Eligibility criteria

Qualifiers

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%

Disqualifiers

Chronic kidney failure with need for dialysis

Metachronous diagnosed cancer

Unable to speak or understand Danish

Cognitive impairment e.g. moderate to severe dementia

Trial design

Treatments tested in this trial

  • Iron(III)isomaltoside
  • Placebo

Treatment groups

134 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Zealand University Hospital

Lead sponsor

Randers Regional Hospital

Collaborator

Slagelse Hospital

Collaborator