Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

Study Overview
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Brief Summary
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The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery. The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside. The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included

Official Title
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Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

Conditions
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Anemia, Colorectal Cancer, Iron-deficiency

Intervention / Treatment
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* Drug: Iron(III)isomaltoside


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing curative intended surgery for colon or rectum cancer UICC stage I-III Exclusion Criteria: Neoadjuvant oncological treatment Acute / subacute surgery Palliative surgery Other pathology than adenocarcinoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Propensity score matched cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron(III)isomaltoside 1000<br>Anemic patients receiving treatment with iron(III)isomaltoside | Drug: Iron(III)isomaltoside<br>* Individual weight and hemoglobin dependent dosage<br>|
| No Intervention: Historical comparison<br>Anemic patients without receiving treatment prior to surgery. Historical comparison. | |
| No Intervention: Concurrent comparison<br>Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression and lymphocyte infiltration of the tumor | 770 gene expression analysis and CD3/CD8+ lymphocyte infiltration of the primary tumor | 1 day after surgery | 
| Complications | Postoperative complications after surgery measured by the Clavien-Dindo classification | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Length of postoperative hospital stay, until discharge or death. | up to 100 days | 
| Readmission | Any readmission over 24 hours in length | Within 30 days after surgery | 
| Time to chemotherapy | Tme from surgery to adjuvant oncological treatment for patients with high risk stage II and stage III disease | up to 100 days | 
| Perioperative blood transfusions | Any blood transfusions measured in ml. | from outpatient assesment to 30 days after surgery | 
| Mortality | Mortality | 30 days, 90 days and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Iron-deficiency anemia