NCT01701310

IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer. At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety. This is a multi-center, randomized, open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. Patients will be randomized to receive intravenous ferric carboxymaltose (treatment group) or oral ferrous sulphate (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles, patient quality of life scores, operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed. The primary hypothesis to be tested is that intravenous iron will decrease transfusion rates. To detect a significant clinical difference in blood transfused consistent with previous published data (1 unit), 58 patients will be required in each arm of the study with 90% power (alpha 0.05). Randomization will be performed independently to the trial team using a computer generated variable block randomization program. All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

Conditions

• Anemia
• Colorectal Neoplasm

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose	A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.
DRUG	Ferrous Sulphate	(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-10-05
• Last updated: 2016-10-28

Locations

8 sites across 1 country: United Kingdom