CompletedPhase 4

IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia

United Kingdom116 participantsStarted 2012-04

Plain-language summary

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 can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 0 - 6 to 12 weeks

Trial details

NCT IDNCT01701310

SponsorNottingham University Hospitals NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

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