Intravenous iron in the management of anaemia in palliative UGI cancer

• Research type

  Research Study

• Full title

  An pilot study to assess the efficacy of intravenous iron isomaltoside 1000 (Monofer®) in the management of anaemia associated with the palliative management of upper gastrointestinal adenocarcinoma

• IRAS ID

  118048

• Contact name

  Austin George Acheson

• Eudract number

  2013-000209-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  There are approximately 16,000 people diagnosed with cancer of the stomach or gullet each year. Unfortunately, these cancers are often inoperable at the time of diagnosis, leaving palliative chemotherapy as the only treatment option available. This chemotherapy regimen is potentially a lengthy course of treatment- lasting up to 6 months. As the primary tumour is not removed, it may continue to bleed over this period causing the patient to chronically lose blood, and anaemia to develop. This can be worsened by the side effects of chemotherapy and compounded by reduced oral intake due to swallowing problems from the tumours themselves. Anaemia is associated with symptoms such as breathlessness, chest pain, lethargy and dizziness. If untreated, these symptoms can seriously impact on patients' quality of life and the ability to complete chemotherapy. Oral iron supplementation has been the mainstay of out-patient treatment for such anaemia. However, some patients do not tolerate it due to gastrointestinal side-effects and difficulty swallowing the tablets due to the tumour. If such measures fail, then blood transfusions may be required. These are associated with the risk of transmission of infection and allergic reactions; hence clinicians often have a higher threshold for administrating them to treat patients' symptoms. Intravenous iron has been used effectively to treat anaemia in other conditions but there is a lack of evidence to prove its use in this context. This study thus aims to investigate the efficacy and safety of intravenous iron in the palliative management of upper gastrointestinal cancers.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  13/EM/0069

• Date of REC Opinion

  20 Mar 2013

• REC opinion

  Further Information Favourable Opinion