IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric carboxymaltose (intervention).

It is hypothesized that intravenous iron supplementation is more efficacious than oral iron therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nottingham University Hospitals NHS Trust
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Ferric Compounds

Criteria

Inclusion criteria:

• Diagnosed with histologically proven colorectal adenocarcinoma.

• Anemic at point of diagnosis of colorectal adenocarcinoma. (Haemoglobin values of <12 g/dL for males and <11 g/dL for females)

• Medically fit for surgery.

• Date of planned surgery is >14 days from date of planned initiation of intervention (intravenous ferric carboxymaltose /oral ferrous sulphate).

• Able and willing to comply with all study requirements.

• Willing to allow his/her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion criteria:

• Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.

• Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected)

• Current chemotherapeutic treatment.

• Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established inflammatory disorders or chronic renal disease).

• Known haematological disease.

• Features necessitating urgent surgery (e.g. obstructive symptoms).

• Previous allergy to intravenous iron or related iron products.

• Significant symptomatic anemia necessitating urgent transfusion (e.g. cardiovascular compromise)

• Patients who are unable to consent.

• Significant renal or hepatic impairment.

• -Donation of blood during the study.

• Participants who have participated in another research study involving an investigational product in the past 12 weeks

• Prisoners and minors (<18 years)

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.