The ADEPT trial was designed to pilot techniques for the identification and management of patients who were scheduled to undergo surgery for colorectal cancer, who had non-anaemic iron deficiency. A group of these patients were to undergo exercise testing, and measurement of total haemoglobin mass. They were then to receive an infusion of intravenous iron or placebo before being tested again to see if their exercise capacity and/or total haemoglobin mass had improved. They were then to be followed during and after their surgery to determine if important outcomes such as requirement for transfusion, physical and mental health and wellbeing and the ability to return to their intended cancer therapy (chemotherapy or radiotherapy) improved because of receiving the study drug.
Austin Health
Associate Professor Lachlan Miles, Professor B Riedel, Ms A Burgess and Associate Professor K Burbury.
The project was awarded funding of $69,166 through the ANZCA research grants program for 2018.
The ADEPT trial was designed to pilot techniques for the identification and management of patients who were scheduled to undergo surgery for colorectal cancer, who had non-anaemic iron deficiency. A group of these patients were to undergo exercise testing, and measurement of total haemoglobin mass. They were then to receive an infusion of intravenous iron or placebo before being tested again to see if their exercise capacity and/or total haemoglobin mass had improved. They were then to be followed during and after their surgery to determine if important outcomes such as requirement for transfusion, physical and mental health and wellbeing and the ability to return to their intended cancer therapy (chemotherapy or radiotherapy) improved because of receiving the study drug.
If the hypothesis of ADEPT were to have been proven, it would have identified a potential reason for failing to respond to exercise training before colorectal cancer surgery and opened an exciting new frontier in preparing patients for these procedures, improving survival and reducing complications from the operation.
Due to the inability to recruit to the trial, the results do not address the research question as asked. However, recruitment to clinical trials can be challenging, and the initial messaging a patient is presented with is extremely important when encouraging their participation. Patients should be informed about the importance of the trial, the direct benefits of their participation, and the commitment inherent in their involvement.
The ADEPT trial, while not being able to elicit a signal that could be used to power subsequent work, nevertheless provided important feasibility information that will influence the design of future protocols. While disappointing, these results highlight important barriers to peri-operative research. Ultimately, clinical trials must enrol participants to generate results that will benefit future practitioners and patients. The ADEPT trial demonstrates the perils of designing a protocol with which potential participations are not motivated to engage and highlights the need for these such trials to provide minimal disruption to patient care where the benefit of the intervention cannot be certain.
The results of the ADEPT trial were presented as a chapter in the PhD thesis of the Chief Investigator and were presented to a University forum as part of the completion seminar.
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