IVICA: Intravenous iron in colorectal cancer associated anaemia

• Research type

  Research Study

• Full title

  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

• IRAS ID

  64507

• Sponsor organisation

  Research and Development Nottingham University Hospital

• Eudract number

  2011-002185-21

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  There are 35,000 cases of colorectal cancer diagnosed each year in the UK. Up to 60% of these patients are diagnosed with anaemia in the pre-operative period. Untreated anaemia is associated with symptoms such as breathlessness, chest pain, lethargy and dizziness. It is also associated with an increased risk for blood transfusion which can result in poorer outcomes for the patient due to increased morbidity and mortality. There is also a risk of transmission of infection with each transfusion. Oral iron supplementation has been the mainstay of treatment of pre-operative anaemia. However, some patients do not tolerate it due to gastrointestinal side-effects and its efficacy remains in question. Intravenous iron has been used effectively to treat anaemia in inflammatory bowel disease but there is a lack of evidence to prove its use in pre-operative anaemia associated with colorectal cancer.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0237

• Date of REC Opinion

  5 Sep 2011

• REC opinion

  Further Information Favourable Opinion