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

Zealand University Hospital

Status: Unknown

Conditions: Anemia; Iron-deficiency; Colorectal Cancer

Treatments: Drug: Iron(III)isomaltoside

Study type: Interventional

Funder types: Other

Identifiers

NCT05221957

REG-056-2020

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Iron(III)isomaltoside 1000

Experimental group

Description:

Anemic patients receiving treatment with iron(III)isomaltoside

Treatment:

Drug: Iron(III)isomaltoside

Historical comparison

No Intervention group

Description:

Anemic patients without receiving treatment prior to surgery. Historical comparison.

Concurrent comparison

No Intervention group

Description:

Non-anemic patients not receiving treatment with iron(III)isomaltoside prior to surgery