A 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 - Intravenous iron in the management of anaemia in palliative UGI cancer

Research and Development Nottingham University Hospital0 个研究点目标入组 27 人开始时间: 2013年5月14日最近更新: 2019年6月30日

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•1.Anaemic as defined by local laboratory normal range(Males<13g/dL, Females<12g/dL)
•2. Male or Female aged over 18years
•3. Participant is willing and able to give informed consent for participation.
•4. Diagnosed with histologically proven oesophageal, gastric or GOJ adenocarcinoma.
•5. Treatment selected is palliative chemotherapy
•6. Medically fit for initiation of palliative chemotherapy.
•7. Able (in the Investigators opinion) and willing to comply with study requirements.
•8. Willing to allow his/her General Practitioner and consultant, if appropriate, to
•be notified of participation in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1. Patients who following investigation do not have a histological diagnosis of
•upper GI adenocarcinoma.
•2. Female participants who are pregnant, lactating or planning a pregnancy during
•the course of the study.
•3. Patients with evidence of iron overload or disturbances in utilisation of iron as
•stated in the product SPC.
•4. Known haematological disease that, in the investigators opinion would confound
•any changes in blood results.
•5. Features necessitating urgent surgery at inclusion
•6. Previous allergy to intravenous iron or related iron products.
•7. Patients who are unable to consent.
•8. 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 study.
•9. Donation of blood during the study.
•10. Prisoners and minors (<18 years)
•11. Non-iron deficiency anaemia (e.g. haemolytic anaemia)
•12. Hypersensitivity to the active substance or to any of the excipients.
•13. Patients with a history of asthma, allergic eczema or other atopic allergy
•14. Decompensated liver cirrhosis and hepatitis
•15. Rheumatoid arthritis with symptoms or signs of active inflammation

发起方

Research and Development Nottingham University Hospital