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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

Phase 4
18 Years
75 Years
Open (Enrolling)
Anemia, Colorectal Neoplasm, Blood Transfusion

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Trial Information

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.

Inclusion 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

0 - 6 to 12 weeks

Safety Issue:


Principal Investigator

Austin G Acheson, MBBS MD FRCS

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United Kingdom: NRES

Study ID:




Start Date:

April 2012

Completion Date:

March 2015

Related Keywords:

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