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Closed (no longer recruiting)Last updated: 3 April 2025

ADEPT: This phase IV trial is trying to understand if infusion of intravenous iron results in improved physical fitness of patients undergoing surgery for colorectal cancerA 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.

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 patients with colorectal cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

IV

Trial Acronym

ADEPT

More information

Trial Identifiers

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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.

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.
Message

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.

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