Iron Replacement in Oesophagogastric Neoplasia (IRON)

October 27, 2016 updated by: Nottingham University Hospitals NHS Trust

An Pilot Study to Assess the Efficacy of Intravenous Iron Isomaltoside 1000 (Monofer®) in the Management of Anaemia Associated With the Palliative Management of Oesophagogastric Adenocarcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Anemia is a common problem to affect patients diagnosed with esophageal or gastric cancer. This anemia is thought to be secondary to blood loss from the tumor, poor oral intake resulting from symptoms of the tumor, and impaired iron absorption secondary to neoplasia induced inflammatory processes.

Patients undergoing palliative chemotherapy for esophageal or gastric adenocarcinoma are thus prone to development or exacerbation of anemia during their chemotherapy, as this tumor is remains in situ.

Anemia results in symptoms such as shortness of breath, fatigue, lethargy and chest pain, which can all affect quality of life. Oral iron and blood transfusions are the current mainstay of treatment for the condition, yet both have their disadvantages. Oral iron is often poorly tolerated due to side effects including constipation, diarrhea, abdominal pain and nausea. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety.

This is a single-center, randomized, open label, clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of anemia in patients with a diagnosis of esophageal or gastric adenocarcinoma.

Patients will be randomized to receive intravenous iron III isomaltoside (treatment group) or standard therapies decided by the clinical team (control). The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles and most importantly, patient quality of life scores. Patients will be followed from the start of their chemotherapy until the beginning of the third cycle.

The primary hypothesis to be tested is that intravenous iron will increase quality of life by reducing the symptoms of anemia. We also hypothesize that there will be a decrease in blood transfusion rate in this group and improved changes in hemoglobin and hematinics.

This is designed as a pilot study to determine the feasibility of a larger trial. Randomization will be performed using random allocation of opaque envelopes. All data will be confidentially recorded, as will drug reactions and side effects.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Recruiting
        • Nottingham Univeristy Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Austin G Acheson, MD FRCS
        • Principal Investigator:
          • Barrie D Keeler, FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
Standard Care as determined by the clinical team
ACTIVE_COMPARATOR: Iron isomaltoside 1000
Intravenous Iron Isomaltoside 1000 (Monofer®)will be administered in line with the summary of product characteristics.
Drug: Iron isomaltoside 1000
Other Names:
  • Monofer®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin differences between groups
Time Frame: 8 months
This will govern the magnitude of treatment effect, and hence aid design of a larger study.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in quality of life
Time Frame: 0-14 weeks
To compare quality of life scores as determined by the EQ-5D and FACT-An questionnaires between treatment groups
0-14 weeks
Number of allogenic red blood cell transfusions administered
Time Frame: 0-14 weeks
To investigate if the number of units transfused per participant, the number of participants whom received a blood transfusion and the total number of units of blood transfused differs between the two study arms. This period monitored will begin at enrolment into the study, and cease at the start of the third cycle of chemotherapy
0-14 weeks
Differences in hematinic markers.
Time Frame: 0 - 14 weeks
To evaluate if hematinic markers (ferritin, iron, transferrin, transferrin) differ between treatment arms.
0 - 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Collaborators

Pharmacosmos A/S

Investigators

  • Principal Investigator: Barrie D Keeler, FRCS, University of Nottingham
  • Study Chair: Austin G Acheson, MD FRCS, University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

August 1, 2017

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 19, 2013

First Posted (ESTIMATE)

August 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12GA029
  • 2013-000209-22 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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