Status:
NOT_YET_RECRUITING
Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Randers Regional Hospital
Slagelse Hospital
Conditions:
Iron-deficiency
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 iro...
Detailed Description
Aim The aim is 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. Study...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT05220800
Start Date
March 1 2022
End Date
March 1 2029
Last Update
March 3 2022
Active Locations (3)
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1
Zealand University Hospital
Køge, Danmark, Denmark, 4600
2
Slagelse Hospital
Slagelse, Danmark, Denmark, 4200
3
Regionshospitalet Randers
Randers, Denmark, 8930