IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia
NCT01701310 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2016-10-28
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.
Conditions
- Anemia
- Colorectal Neoplasm
Interventions
- 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
Sponsors & Collaborators
-
National Institute for Health Research, United Kingdom
collaborator OTHER_GOV -
Nottingham University Hospitals NHS Trust
lead OTHER
Principal Investigators
-
Austin G Acheson, MBBS MD FRCS · Nottingham University Hospitals NHS Trust, Nottingham University, School of Clinical Sciences, Division of GI Surgery
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2014-12-31
- Completion
- 2014-12-31
Countries
- United Kingdom
Study Locations
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