AnemiaPhase 4IRONNCT01927328
Iron Replacement in Oesophagogastric Neoplasia
A Phase 4 study testing Iron isomaltoside 1000 in people with Anemia and Esophageal Cancer, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Esophageal Cancer, Gastric Cancer
- What is being tested?
- Iron isomaltoside 1000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham Univeristy Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Barrie D Keeler, FRCS, 0115 82 31145, barriekeeler@doctors.org.uk
Austin G Acheson, MD FRCS
About this study
Official title: 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.
Read the 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.
- Conditions
- Anemia, Esophageal Cancer, Gastric Cancer
- Being tested
- Iron isomaltoside 1000
- Keywords
- Adenocarcinoma, Anemia, Palliative therapy, Palliative care, Palliative treatments, Chemotherapy, Esophageal Cancer, Gastric Cancer
- Medical subject headings
- Anemia, Esophageal Neoplasms, Stomach Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltoside 1000Drug
Also called Monofer®
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Iron isomaltoside 1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin differences between groups
This will govern the magnitude of treatment effect, and hence aid design of a larger study.
Measured: 8 months
Secondary outcomes (3)
Differences in quality of life
To compare quality of life scores as determined by the EQ-5D and FACT-An questionnaires between treatment groups
Measured: 0-14 weeks
Number of allogenic red blood cell transfusions administered
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
Measured: 0-14 weeks
Differences in hematinic markers.
To evaluate if hematinic markers (ferritin, iron, transferrin, transferrin) differ between treatment arms.
Measured: 0 - 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmacosmos A/S
- Responsible party
- Sponsor
- Investigators
- Barrie D Keeler, FRCS, Principal investigator, University of NottinghamAustin G Acheson, MD FRCS, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927328
- Sponsor's protocol ID
- 12GA029
- Other IDs
- 2013-000209-22
- Acronym
- IRON
- Status last verified
- Oct 2016
- First submitted
- 5 Aug 2013
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01927328
- Acronym / sponsor ID
- IRON / 12GA029
- Conditions
- Anemia, Esophageal Cancer, Gastric Cancer
- Keywords
- Adenocarcinoma, Anemia, Palliative therapy, Palliative care, Palliative treatments, Chemotherapy, Esophageal Cancer, Gastric Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Pharmacosmos A/S
- Study start
- Aug 2013
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 22 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard Care as determined by the clinical team |
| Iron isomaltoside 1000 | Active comparator | Drug: Iron isomaltoside 1000Intravenous Iron Isomaltoside 1000 (Monofer®)will be administered in line with the summary of product characteristics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron isomaltoside 1000Also: Monofer® | Drug | Iron isomaltoside 1000 |
Primary outcome
Hemoglobin differences between groups
Time frame: 8 months
This will govern the magnitude of treatment effect, and hence aid design of a larger study.
3 secondary outcomes
Differences in quality of life
Time frame: 0-14 weeks
Number of allogenic red blood cell transfusions administered
Time frame: 0-14 weeks
Differences in hematinic markers.
Time frame: 0 - 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barrie D Keeler, FRCS principal investigator
University of Nottingham
Austin G Acheson, MD FRCS study chair
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iron isomaltoside 1000 in people with Anemia and Esophageal Cancer, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barrie D Keeler, FRCS (0115 82 31145, barriekeeler@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin differences between groups (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.