Preoperative i.v. Iron Substitution in Patients With Colon Cancer (PREFECO)

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Colon Cancer

Treatments: Drug: Ferric carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT04653181

SKoskensalo

Details and patient eligibility

About

About 70% of colon cancer patients are anemic. Preoperative anemia in patients with colorectal cancer is associated with both impaired disease-free survival and overall survival. The purpose of this study is to compare the effects of preoperative iv iron substitution on postoperative recovery in preoperatively anemic (male Hb <130, female Hb <120) and iron deficient colon cancer patients in a prospective setup. As a primary outcome, the effect of iv-iron substitution on postoperative complications is investigated.

Full description

Randomized preoperative iron substitution for patient with iron deficient anemia

Enrollment: 514 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age> 18 years
• Dg: Colon ca
• The planned measure: the colon resection
• Men: Hb <130, women: Hb <120 and iron deficiency (elevated TfR, low TrFesat or low ferritin)

Exclusion criteria

• hyperreactivity for Ferinject
• haemochromatosis
• refusal for participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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514 participants in 2 patient groups

Iron arm

Experimental group

Description:

Half of patients get i.v. iron preoperatively

Treatment:

Drug: Ferric carboxymaltose

non-iron arm

No Intervention group

Description:

Half of patients are treated without i.v. iron substitution