Anemia Clinical Trial
— IVICAOfficial title:
An Open Label Study to Determine the Efficacy of Ferric Carboxymaltose in Preoperative Colorectal Cancer Related Anaemia, and to Develop Biomarkers to Predict Response to This Treatment Strategy
116 eligible patients with confirmed non-metastatic colorectal adenocarcinoma and anemia
will be randomized to receive either oral ferrous sulphate (control) or intravenous ferric
carboxymaltose (intervention).
It is hypothesized that intravenous iron supplementation is more efficacious than oral iron
therapy.
Status | Completed |
Enrollment | 116 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Diagnosed with histologically proven colorectal adenocarcinoma. - Anemic at point of diagnosis of colorectal adenocarcinoma. (Haemoglobin values of <12 g/dL for males and <11 g/dL for females) - Medically fit for surgery. - Date of planned surgery is >14 days from date of planned initiation of intervention (intravenous ferric carboxymaltose /oral ferrous sulphate). - Able and willing to comply with all study requirements. - Willing to allow his/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. - Previous gastric, small bowel or colorectal surgery (where =50% of stomach or terminal ileum has been resected) - Current chemotherapeutic treatment. - Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established inflammatory disorders or chronic renal disease). - Known haematological disease. - Features necessitating urgent surgery (e.g. obstructive symptoms). - Previous allergy to intravenous iron or related iron products. - Significant symptomatic anemia necessitating urgent transfusion (e.g. cardiovascular compromise) - Patients who are unable to consent. - Significant renal or hepatic impairment. - -Donation of blood during the study. - Participants who have participated in another research study involving an investigational product in the past 12 weeks - Prisoners and minors (<18 years) - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Birmingham | Birmingham | West Midlands |
United Kingdom | University Hospitals Bristol Foundation NHS Turst | Bristol | |
United Kingdom | Derby Hospital NHS Foundation Trust | Derby | |
United Kingdom | St James University Hospitals NHS Trust | Leeds | |
United Kingdom | University Hospitals of Leicester NHS Trust | Leicester | |
United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | |
United Kingdom | Royal Wolverhampton Hospitals NHS Trust | Wolverhampton | West Midlands |
United Kingdom | Yeovil District Hospital NHS Foundation Trust | Yeovil |
Lead Sponsor | Collaborator |
---|---|
Nottingham University Hospitals NHS Trust | National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine if the use of intravenous ferric carboxymaltose can reduce the need for allogeneic blood transfusion compare to oral ferrous sulphate in patients with colorectal adenocarcinoma related anaemia | To investigate if the number of units transfused per participant, the number of participants whom receive 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 review in outpatient clinic 6 - 12 weeks post operatively. | 0 - 6 to 12 weeks | Yes |
Secondary | To determine differences in hemoglobin and hematinic markers between the groups. | Hematinic markers include ferritin, iron, transferrin, transferrin saturation, erythropoietin. | Enrollment to 6-12 weeks postoperatively | No |
Secondary | To determine differences in hepcidin levels in relation to blood profile changes in participants in the intravenous group. | To review the use of hepcidin as a biomarker to predict response to therapy. | Enrollment to 6-12 weeks postoperatively. | No |
Secondary | To determine differences in colonic mucosal expression of iron transport proteins, C-myc and NKD1 between the groups | Iron transport proteins include DMT TFR1, Ferroportin, Ferritin. As acquired from examination of pathology tissue specimen excised. | At point of operation only | No |
Secondary | To determine differences in postoperative outcomes between the groups. | Post-operative outcomes include morbidity, mortality, length of stay. | Enrollment to 6-12 weeks postoperatively | No |
Secondary | To determine differences in anemia symptomatology response between groups. | Quality of Life questionnaires will be used (SF-36[short form 36] and EQ-5D) | Enrollment to 6-12 weeks postoperatively | No |
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