RecruitingPhase 4ACTRN12616001219471

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


Sponsor

Peter MacCallum Cancer Centre

Enrollment

36 participants

Start Date

Oct 31, 2016

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot study is looking at whether giving an iron infusion to patients with colorectal cancer who are iron-deficient before their surgery can improve their physical fitness. Patients who are iron-deficient but not severely anaemic will be randomly assigned to receive either an iron infusion or a saline (salt water) infusion, and their fitness will be measured before and after. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with colorectal cancer confirmed by biopsy - You have low iron levels (ferritin below 100, or between 100–300 with low transferrin saturation) - You are scheduled for colorectal surgery - Your vitamin B12 and folate levels are normal You may NOT be eligible if: - Your anaemia is very severe (haemoglobin below 110 mg/dL and ferritin below 20) - You have received iron therapy or a blood transfusion in the past 12 weeks - You have had an allergic reaction to iron infusions before - You have liver disease or a blood disorder like haemochromatosis - You have a physical disability preventing exercise testing Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

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)

Peter MacCallum Cancer Centre - Melbourne

VIC, Australia

Epworth Richmond - Richmond

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12616001219471


Related Trials