IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

NCT ID: NCT01701310

Last Updated: 2016-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-12-31

Brief 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

Keywords

Adenocarcinoma; Anemia; Blood Transfusion; Colorectal surgery; Preoperative care; Perioperative care; Postoperative care; Iron; Hematinics; Hepcidin; Quality of life; Postoperative complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferric carboxymaltose

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.

Ferrous Sulphate

Group Type: ACTIVE_COMPARATOR

Ferrous Sulphate

Intervention Type: DRUG

(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Interventions

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.

Intervention Type: DRUG

Ferrous Sulphate

(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Intervention Type: DRUG

Other Intervention Names

Ferinject®

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Austin G Acheson, MBBS MD FRCS

Role: STUDY_CHAIR

Nottingham University Hospitals NHS Trust, Nottingham University, School of Clinical Sciences, Division of GI Surgery

Locations

Nottingham University Hospitals NHS Trust

Nottingham, Nottingham, United Kingdom

University Hospital Birmingham

Birmingham, West Midlands, United Kingdom

Royal Wolverhampton Hospitals NHS Trust

Wolverhampton, West Midlands, United Kingdom

University Hospitals Bristol Foundation NHS Turst

Bristol, , United Kingdom

Derby Hospital NHS Foundation Trust

Derby, , United Kingdom

St James University Hospitals NHS Trust

Leeds, , United Kingdom

University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Yeovil District Hospital NHS Foundation Trust

Yeovil, , United Kingdom

Countries

United Kingdom

Other Identifiers

2011-002185-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PB-PG-0110-21041

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

11GS005

Identifier Type: -

Identifier Source: org_study_id