Iron Replacement in Oesophagogastric Neoplasia

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

40 eligible patients with confirmed esophageal or gastric adenocarcinoma and anemia will be randomized to a control or intervention group for management of this anemia. The control group treatment will consist of standard treatments as governed by the clinical team (eg oral iron, blood transfusions) whilst the intervention group will be treated with intravenous iron III isomaltoside (Monofer ®).

It is hypothesized that intravenous iron supplementation is more efficacious than standard therapies.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nottingham University Hospitals NHS Trust
• Collaborator: Pharmacosmos A/S
• Treatments: Ferric Compounds; Iron; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

• Participant is willing/able to give informed consent for study participation.

• Male or Female, aged 18+

• Anemic with hemoglobin values <13 g d/L for males & < 11.5 g/dL for females.

• Diagnosed with histologically proven esophageal,gastric or Gastro-esophageal Junctional adenocarcinoma.

• Treatment selected is palliative chemotherapy.

• Medically fit for initiation of palliative chemotherapy.

• Able (in the Investigators opinion) & willing to comply with all study aspects.

• Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

• Patients who following investigation do not have a histological diagnosis of upper GI adenocarcinoma

• Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.

• Patients with evidence of iron overload or disturbances in utilization of iron as stated in the product Summary of Product Characteristics.

• Known hematological disease that, in the investigators opinion would confound any changes in blood results.

• Features necessitating urgent surgery.

• Previous allergy to intravenous iron or related iron products.

• Patients who are unable to consent.

• 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.

• Donation of blood during the study.

• Prisoners and minors (<18 years).

• Non-iron deficiency anaemia (e.g. haemolytic anaemia).

• Hypersensitivity to the active substance or to any of the excipients.

• Patients with a history of asthma, allergic eczema or other atopic allergy.

• Decompensated liver cirrhosis and hepatitis.

• Rheumatoid arthritis with symptoms or signs of active inflammation.