Intravenous iron in the management of anaemia in palliative oesophageal and gastric cancer

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000209-22-GB
• Lead Sponsor: Research and Development Nottingham University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-14
• Study Completion: 2017-08-28
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified