Impact of Non-Anaemic Iron Deficiency Correction on Exercise Capacity and Perioperative Outcomes in Colorectal Cancer Surgery

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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001437257

Acronym

ADEPT

Enrollment

Registered

2018-08-28

Start date

2019-03-18

Completion date

2020-01-21

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

What is this study? The purpose of this trial is to determine whether an infusion of intravenous iron results in improved exercise capacity or iron levels in the blood in patients undergoing surgery for colorectal cancer. Who is it for? You may be eligible for this study if you are an adult scheduled to undergo elective surgery for colorectal cancer who has iron deficiency. Study details 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, and will help improve physical and mental health during their cancer treatment.

Interventions

Ferric carboxymaltose, 20mg/kg (up to 1000mg) in 500mL 0.9% sodium chloride administered intravenously. A single dose will be administered under direct observation of the study team.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Patient scheduled to undergo elective open or laparoscopic surgery for colorectal cancer; 2) Iron deficiency at initial booking for surgery.

Exclusion criteria

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.

Outcome results