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
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 minimise
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 mutli-center, randomised, 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 randomised 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 treament 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).
Randomisation will be performed independently to the trial team using a computer generated
variable block randomisation program.
All data will be confidentially recorded on a CRF, as will drug reactions and side effects.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine if the use of intravenous ferric carboxymaltose can reduce the need for allogeneic blood transfusion compare to oral ferrous sulphate in patients with colorectal adenocarcinoma related anaemia
To investigate if the number of units transfused per participant, the number of participants whom receive a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at review in outpatient clinic 6 - 12 weeks post operatively.
0 - 6 to 12 weeks
Austin G Acheson, MBBS MD FRCS
Nottingham University Hospitals NHS Trust, Nottingham University, School of Clinical Sciences, Division of GI Surgery
United Kingdom: NRES