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
Sponsors and collaborators
Zealand University Hospital
Lead sponsor
Randers Regional Hospital
Collaborator
Slagelse Hospital
Collaborator