Iron infusion in iron-deficient patients undergoing surgery for colorectal cancer who are anaemic versus not anaemic in order to improve physical fitness as determined by exercise testing and a quality of life questionnaire.
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
Peter MacCallum Cancer Centre
36 participants
Oct 31, 2016
Interventional
Conditions
Summary
This pilot study aims to test if an iron infusion to iron-deficient patients planned for surgery for colorectal cancer who are anaemic versus not anaemic will improve physical fitness. Who is it for? You may be eligible to join this study if you are aged 18 years and above, have histologically confirmed colorectal cancer and Ferritin of less than 100mcg/l or between 100-300mcg/L with a transferrin saturation of less than %20. Study details Consenting participants will be randomly (by chance) allocated to either receive an infusion enriched with 1000mg iron (Ferric Carboxymaltose) or 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. This project is a pilot study, and if feasible, may be extended to a larger study in the future. This project is being conducted at Peter MacCallum Cancer Centre and Epworth Health Care.
Eligibility
Inclusion Criteria6
- Patients 18 years of age and older
- Patients with histologically confirmed colorectal cancer presenting to Peter MacCallum Cancer Centre, or Epworth Hospital (Richmond and Eastern campuses).
- Ferritin <100mcg/l or 100-300mcg/L and TSAT<20%
- Normal Serum Vitamin B12 and Folate levels
- Normal red cell folate and B12 levels
- Patients planned for surgery colorectal surgery
Exclusion Criteria13
- Hb (>130mg/dL male, or >120mg/dL female) & (either one of: Ferritin >300mcg/l, or Ferritin >100mcg/l and TSAT >20%)
- Marked Iron deficiency anaemia precluding randomization: Hb < 110 mg/dL & Ferritin <20 mcg/l
- Iron therapy contraindicated
- Treatment with iron therapy or blood transfusion in the previous 12 weeks
- Presentation for neoadjuvant CRT or Surgery within the study period
- Patients with a known haematological abnormality (such as haemochromatosis or thalassemia, TSAT >50%)
- Liver disease where ALT is above 3 times the upper limit of the normal range
- Patients with a history of acquired iron overload or iron storage disorders
- Previous hypersensitivity or allergic reactions to parentral (polymaltose/carboxymaltose) iron preparations
- Patients unable to give informed consent
- Physical disability preventing CPX, or contraindication in local CPX policy (such as angina at rest)
- Patients included in other clinical trials that involve the administration of iron therapy
- Blood transfusion in previous three months
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Interventions
Intervention will occur independent of date of surgery. The follow-up date will occur before date of surgery. Control treatment will occur independent of date of surgery. The follow-up date will occur before date of surgery. This means that FCM will be administered at least 2 weeks before any further intervention, such as neoadjuvant chemotherapy or surgery. This will not cause any delay in normal treatment. After baseline CPX is performed (Day 0), participants will receive 1000mg of Ferric Carboxymaltose (FCM) in a maximum of 250mls of 0.9% saline solution; Ferinject, Vifor Pharma, Glattbrugg, Switzerland) 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. Adherence to FCM will be monitored as the patient will be monitored on the ward.
Locations(2)
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ACTRN12616001219471