Trial purpose
Cancer treatment; Side effect and wellbeing
Tumor type
Lower gastrointestinal tract
Age
18+
Clinical summary
Summary
All participants in this study will undergo an exercise stress test and undergo a blood test. Participants will then be randomly allocated to either receive an iron infusion or to receive placebo. A few weeks after their infusion, participants will undergo exercise testing again and complete a number of questionnaires. They will then have their surgery, and be interviewed 30 and 90 days after surgery to assess their recovery. It is hoped that this research will help determine whether iron infusions are beneficial for those with iron deficiency undergoing colorectal cancer surgery, and will help improve physical and mental health during their cancer treatment.
Conditions
This trial is treating people with colorectal cancer who are scheduled to undergo elective surgery and have an iron deficiency
Eligibility
Inclusion
1) Patient scheduled to undergo elective open or laparoscopic surgery for colorectal cancer;
2) Iron deficiency at initial booking for surgery.
Exclusion
Emergency or inpatient surgery;
Pregnancy;
Age < 18 years
Known or suspected haemoglobinopathy;
Bone marrow disease;
Haemochromatosis;
End-stage renal failure requiring dialysis;
Erythropoetin or iron supplementation in the preceding four weeks;
Haemoglobin < 120g.L-1 for women or < 130 g.L-1 for men;
Contraindication to cardiopulmonary exercise testing;
Active smoking history;
Known allergy to ferric carboxymaltose.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Vifor Pharma Pty Ltd,ANZCA Research Foundation & Austin Health
Scientific Title
A pilot double-blind parallel-group placebo controlled randomised trial of the effect of preoperative ferric carboxymaltose infusion on total haemoglobin mass and exercise capacity in patients with non-anaemic iron deficiency undergoing major surgery for colorectal cancer.
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information