Health TrialsbyHealthPanel

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

ConditionsIron-deficiencyColorectal 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Iron(III)isomaltoside

    Drug

    Weight-dependent dosage of iron(III)isomaltoside. See group descriptions

  • Placebo

    Drug

    Isoton saline infusion

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Iron(III)isomaltoside 1000Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in oxygen uptake at the anaerobic threshold

Change in oxygen uptake at the anaerobic threshold measured by cardiopulmonary exercise test before infusion and the days before surgery

Time frame
at baseline and 1-4 days before surgery
2

Change in neutrophile to lymphocyte ratio (NLR)

Change in neutrophile to lymphocyte ratio (NLR) between baseline bloodwork and prior to surgery.

Time frame
at baseline and 1-4 days before surgery
3

Changes in T-cell function - mRNA expression analysis

Nanostring pancancer immune analysis of tumor samples

Time frame
1 day after surgery

Secondary outcomes

1

Quality of Recovery 15 (QoR-15)

Questionaire Quality of Recovery 15 (QoR-15). Scale of 15 questions regarding surgical recovery. Each item with a maximum score of 10 and minimum of 0. Total maximum score 150. Lowest 0. The higher score the better recovery

Time frame
Up to 7 days after surgery
2

Complications

Postoperative complications graded by the Clavien-Dindo classification and the comprehensive complication index

Time frame
30-days after surgery
3

Days alive and out of hospital - 30

Days alive and out of hospital 30 days after surgery

Time frame
30 days after surgery
4

1 year cancer free survival

1 year cancer free survival. Either death or recurrence

Time frame
1 year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zealand University Hospital

Lead sponsor

Randers Regional Hospital

Collaborator

Slagelse Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: