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Anemia | IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

Anemia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Anemia

Colorectal Neoplasm

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Ferric carboxymaltoseA minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.

Drug:Ferrous Sulphate(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ferric carboxymaltose

Ferrous Sulphate

Study Status

Completed

Start Date: April 2012

Completed Date: December 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: 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

Secondary Outcome: To determine differences in hemoglobin and hematinic markers between the groups.

Study sponsors, principal investigator, and references

Principal Investigator: Austin G Acheson, MBBS MD FRCS

Lead Sponsor: Nottingham University Hospitals NHS Trust

Collaborator: National Institute for Health Research, United Kingdom

More information:https://clinicaltrials.gov/show/NCT01701310

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