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RecruitingLast updated: 2 February 2024

FeRIC (Fe dEficiency in ColoRectal Cancer): This phase IV trial is trying to determine if giving an iron infusion to iron-deficient colorectal cancer patients who are anaemic versus not anaemic will improve their physical fitness for planned surgeryAn iron infusion with Ferric Carboxymaltose as a technique of improving physiological reserve in iron deficient patients undergoing surgery for colorectal cancer: a randomized control trial

Clinical summary

Summary

Eligible patients will be randomly (by chance) allocated to receive an infusion enriched with 1000mg iron (Ferric Carboxymaltose) OR a saline solution of similar appearance. All participants will receive maximum of 250mls of 0.9% saline solution with or without iron (depending on group) over a 15 minute period. All patients will be monitored for 30 minutes following completion of the infusion. No further blood tests will be required on the day of the infusion.

Conditions

This trial is treating patients with colorectal cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

IV

Trial Acronym

FeRIC (Fe dEficiency in ColoRectal Cancer)

More information

Trial Identifiers

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Trial sponsor

Peter MacCallum Cancer Centre

Scientific Title

An iron infusion with Ferric Carboxymaltose as a technique of improving physiological reserve in iron deficient patients undergoing surgery for colorectal cancer: a randomized control trial

Eligibility

Inclusion

1. Patients 18 years of age and older
2. Patients with histologically confirmed colorectal cancer presenting to Peter MacCallum Cancer Centre, or Epworth Hospital (Richmond and Eastern campuses).
3. Ferritin <100mcg/l or 100-300mcg/L and TSAT<20%
4. Normal Serum Vitamin B12 and Folate levels
5. Normal red cell folate and B12 levels
6. Patients planned for surgery colorectal surgery

Exclusion

 

1. Hb (>130mg/dL male, or >120mg/dL female) & (either one of: Ferritin >300mcg/l, or Ferritin >100mcg/l and TSAT >20%)
2. Marked Iron deficiency anaemia precluding randomization: Hb < 110 mg/dL & Ferritin <20 mcg/l
3. Iron therapy contraindicated
4. Treatment with iron therapy or blood transfusion in the previous 12 weeks
5. Presentation for neoadjuvant CRT or Surgery within the study period
6. Patients with a known haematological abnormality (such as haemochromatosis or thalassemia, TSAT >50%)
7. Liver disease where ALT is above 3 times the upper limit of the normal range
8. Patients with a history of acquired iron overload or iron storage disorders
9. Previous hypersensitivity or allergic reactions to parentral (polymaltose/carboxymaltose) iron preparations
10. Patients unable to give informed consent
11. Physical disability preventing CPX, or contraindication in local CPX policy (such as angina at rest)
12. Patients included in other clinical trials that involve the administration of iron therapy
13. Blood transfusion in previous three months

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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