Iron Replacement in Oesophagogastric Neoplasia (IRON)
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|ClinicalTrials.gov Identifier: NCT01927328|
Recruitment Status : Unknown
Verified October 2016 by Nottingham University Hospitals NHS Trust.
Recruitment status was: Recruiting
First Posted : August 22, 2013
Last Update Posted : October 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Anemia Esophageal Cancer Gastric Cancer||Drug: Iron isomaltoside 1000||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
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 Name: Monofer®
- Hemoglobin differences between groups [ Time Frame: 8 months ]This will govern the magnitude of treatment effect, and hence aid design of a larger study.
- 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
- 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
- Differences in hematinic markers. [ Time Frame: 0 - 14 weeks ]To evaluate if hematinic markers (ferritin, iron, transferrin, transferrin) differ between treatment arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927328
|Contact: Barrie D Keeler, FRCS||0115 82 firstname.lastname@example.org|
|Contact: Austin G Acheson, MD FRCS||0115 82 email@example.com|
|Nottingham Univeristy Hospitals NHS Trust||Recruiting|
|Nottingham, Nottinghamshire, United Kingdom, NG7 2UH|
|Contact: Barrie D Keeler, FRCS 0115 82 31145 firstname.lastname@example.org|
|Principal Investigator: Austin G Acheson, MD FRCS|
|Principal Investigator: Barrie D Keeler, FRCS|
|Principal Investigator:||Barrie D Keeler, FRCS||University of Nottingham|
|Study Chair:||Austin G Acheson, MD FRCS||University of Nottingham|