Iron Replacement in Oesophagogastric Neoplasia

NCT01927328 | Unknown Phase 4

• 2 other identifiers: 12GA0292013-000209-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anemia; Esophageal Cancer; Gastric Cancer

Keywords

Adenocarcinoma; Anemia; Palliative therapy; Palliative care; Palliative treatments; Chemotherapy; Esophageal Cancer; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Hemoglobin differences between groups

  This will govern the magnitude of treatment effect, and hence aid design of a larger study.

  8 months

Secondary Outcomes (3)

• Differences in quality of life

  0-14 weeks

• Number of allogenic red blood cell transfusions administered

  0-14 weeks

• Differences in hematinic markers.

  0 - 14 weeks

Study Arms (2)

Control

NO INTERVENTION

Standard Care as determined by the clinical team

Iron isomaltoside 1000

ACTIVE COMPARATOR

Intravenous Iron Isomaltoside 1000 (Monofer®)will be administered in line with the summary of product characteristics.

Drug: Iron isomaltoside 1000

Interventions

Iron isomaltoside 1000 DRUG

Also known as: Monofer®

Iron isomaltoside 1000

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• Pharmacosmos A/S: collaborator

Study Sites (1)

Nottingham Univeristy Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anemia; Esophageal Neoplasms; Stomach Neoplasms; Adenocarcinoma

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Barrie D Keeler, FRCS

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Austin G Acheson, MD FRCS

  University of Nottingham

  STUDY CHAIR

Central Study Contacts

Barrie D Keeler, FRCS

CONTACT

0115 82 31145; barriekeeler@doctors.org.uk

Austin G Acheson, MD FRCS

CONTACT

0115 82 31147; austin.acheson@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 22, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

GB (1)