Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2013-08-31
2017-08-31
Brief Summary
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It is hypothesized that intravenous iron supplementation is more efficacious than standard therapies.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Standard Care as determined by the clinical team
No interventions assigned to this group
Iron isomaltoside 1000
Intravenous Iron Isomaltoside 1000 (Monofer®)will be administered in line with the summary of product characteristics.
Iron isomaltoside 1000
Interventions
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Iron isomaltoside 1000
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pharmacosmos A/S
INDUSTRY
Nottingham University Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Barrie D Keeler, FRCS
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Austin G Acheson, MD FRCS
Role: STUDY_CHAIR
University of Nottingham
Locations
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Nottingham Univeristy Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Barrie D Keeler, FRCS
Role: primary
Other Identifiers
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2013-000209-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12GA029
Identifier Type: -
Identifier Source: org_study_id