The medical condition to be investigated is anaemia in patients with oesophageal or gastric cancer planned to undergo palliative chemotherapy. MedDRA version: 18.1 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000004851
Conditions
Interventions
Trade Name: Monofer®
Product Name: Monofer
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: IRON
Concentration
Sponsors
Research and Development Nottingham University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Anaemic as defined by local laboratory normal range(Males=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the feasibility of a larger trial, ie determine study size, ensure logistics adequate, to review patient uptake etc.; Secondary Objective: To investigate whether the use of intravenous Iron (Monofer®) improves the quality of life of patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma. To investigate whether the use of intravenous Iron (Monofer®) reduces the need for blood transfusions in patients undergoing palliative treatment of upper gastrointestinal acancer (adenocarcinoma). To assess whether the use of intravenous Iron (Monofer®) improves the outcome, e.g in terms of complication rates and chemotherapy completion rates, in patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma. To investigate whether the use of intravenous Iron (Monofer®) improves the blood results of patients undergoing palliative treatment of upper gastrointestinal adenocarcinoma. These blood results reflect iron stores in the body ;Primary end point(s): This is a Pilot study to assess feasibilty of a larger trial. We hope to review patient uptake, drop out, logistics of iron administration etc to aid in the design of a larger study.; Timepoint(s) of evaluation of this end point: At recruitment (T=0). On the first day of chemotherapy cycle 1 (T= approx +4 weeks) On the first day of chemotherapy cycle 3 (T= approx +7 weeks) On the first day of chemotherapy cycle 3 (T= approx +10 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in quality of life as defined by the EQ-5D and FACT-an validated quality of life questionnaires. Variations in levels of haemoglobin and haematinic markers (full blood count, ferritin, iron, transferrin, transferrin saturation, erythropoietin). Rates of blood transfusion pre and intra-operatively. ; Timepoint(s) of evaluation of this end point: At recruitment (T=0). On the first day of chemotherapy cycle 1 (T= approx +4 weeks) On the first day of chemotherapy cycle 3 (T= approx +7 weeks) On the first day of chemotherapy cycle 3 (T= approx +10 weeks) | — |
Countries
United Kingdom
Contacts
Public ContactOliver Ng
Nottingham University
Outcome results
None listed