Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001437257
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
28/08/2018
Date last updated
9/08/2021
Date data sharing statement initially provided
9/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Non-Anaemic Iron Deficiency Correction on Exercise Capacity and Perioperative Outcomes in Colorectal Cancer Surgery
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.
Secondary ID [1] 295865 0
None
Universal Trial Number (UTN)
U1111-1219-2432
Trial acronym
ADEPT
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 309330 0
Colorectal cancer 309331 0
Perioperative medicine 309332 0
Condition category
Condition code
Blood 308194 308194 0 0
Anaemia
Anaesthesiology 308195 308195 0 0
Other anaesthesiology
Surgery 308196 308196 0 0
Other surgery
Cancer 308198 308198 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312200 0
Treatment: Drugs
Comparator / control treatment
Equivalent volume of 0.9% sodium chloride administered intravenously. A single dose will be administered under the direct observation of the study team.
Control group
Placebo

Outcomes
Primary outcome [1] 307161 0
Change in V'O2 peak measured by cardiopulmonary exercise testing. The test will be conducted using an electromagnetically braked cycle ergometer with a 20W ramp protocol.
Timepoint [1] 307161 0
Measured at baseline and three weeks following administration of study drug
Secondary outcome [1] 350934 0
Change in anaerobic threshold measured by cardiopulmonary exercise testing. The test will be conducted using an electromagnetically braked cycle ergometer with a 20W ramp protocol.
Timepoint [1] 350934 0
Measured at baseline and three weeks following administration of study drug
Secondary outcome [2] 350935 0
Change in haemoglobin concentration (g/L) measured by laboratory assay.
Timepoint [2] 350935 0
Measured at baseline and three weeks following administration of study drug
Secondary outcome [3] 350936 0
Change in quality of life as measured by EQ-5D-5L
Timepoint [3] 350936 0
Measured at baseline and three weeks following administration of study drug, and at 30 days post-operatively
Secondary outcome [4] 350937 0
Change in disability and functional capacity as measured by WHODAS 2.0
Timepoint [4] 350937 0
Measured at baseline and at post-operative day 90
Secondary outcome [5] 350938 0
Recovery from surgery as measured by QoR-15
Timepoint [5] 350938 0
Post-operative day 3
Secondary outcome [6] 350939 0
Requirement for allogeneic blood transfusion as assessed from the medical record.
Timepoint [6] 350939 0
Discharge from hospital after index surgery
Secondary outcome [7] 350941 0
Days alive and out of hospital as reported by the patient, and, if necessary, assessment of the medical record.
Timepoint [7] 350941 0
Post-operative day 90
Secondary outcome [8] 350942 0
Return to intended oncological therapy as reported by the patient, and, if necessary, assessment of the medical record.
Timepoint [8] 350942 0
Post-operative day 90
Secondary outcome [9] 350943 0
Post-operative complication (infection, MINS, return to theatre, etc.) as reported by the patient, and, if necessary, assessment of the medical record.
Timepoint [9] 350943 0
Post-operative day 90
Secondary outcome [10] 350944 0
Readmission to acute care as reported by the patient, and, if necessary, assessment of the medical record.
Timepoint [10] 350944 0
Post-operative day 90
Secondary outcome [11] 351143 0
Change in serum ferritin (mcg/L) as measured by laboratory assay.
Timepoint [11] 351143 0
Measured at baseline and three weeks following administration of study drug
Secondary outcome [12] 351144 0
Change in serum transferrin saturation (%) as measured by laboratory assay.
Timepoint [12] 351144 0
Measured at baseline and three weeks following administration of study drug
Secondary outcome [13] 351145 0
Change in serum hepcidin (ng/mL) as measured by laboratory assay.
Timepoint [13] 351145 0
Measured at baseline and three weeks following administration of study drug

Eligibility
Key inclusion criteria
1) Patient scheduled to undergo elective open or laparoscopic surgery for colorectal cancer;
2) Iron deficiency at initial booking for surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer algorithm
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Student’s T-test or Wilcoxon rank-sum test depending on normality.
Chi-squared test or Fisher's exact test for categorical data.
Cox proportional hazards model or quantile regression will be used to analyse the secondary outcome measure (DAoH-90).

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
10/09/2018
Actual
18/03/2019
Date of last participant enrolment
Anticipated
15/09/2020
Actual
21/01/2020
Date of last data collection
Anticipated
15/12/2020
Actual
18/05/2020
Sample size
Target
40
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11696 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 11697 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 23776 0
3084 - Heidelberg
Recruitment postcode(s) [2] 23777 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 300462 0
Charities/Societies/Foundations
Name [1] 300462 0
ANZCA Research Foundation
Country [1] 300462 0
Australia
Funding source category [2] 300508 0
Commercial sector/Industry
Name [2] 300508 0
Vifor Pharma Pty Ltd
Country [2] 300508 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
HEIDELBERG VIC 3084
Country
Australia
Secondary sponsor category [1] 299931 0
None
Name [1] 299931 0
None
Address [1] 299931 0
None
Country [1] 299931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301265 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301265 0
145 Studley Road
HEIDELBERG VIC 3084
Ethics committee country [1] 301265 0
Australia
Date submitted for ethics approval [1] 301265 0
18/09/2017
Approval date [1] 301265 0
30/11/2017
Ethics approval number [1] 301265 0
HREC/17/Austin/469

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86418 0
Dr Lachlan Miles
Address 86418 0
Department of Anaesthesia
Austin Health
Level 2, Austin Tower
145 Studley Road
HEIDELBERG VIC 3084
Country 86418 0
Australia
Phone 86418 0
+61394965704
Fax 86418 0
Email 86418 0
[email protected]
Contact person for public queries
Name 86419 0
Ms Sam McKeown
Address 86419 0
Department of Cancer Surgery
Peter MacCallum Cancer Centre
305 Grattan Street
MELBOURNE VIC 3000
Country 86419 0
Australia
Phone 86419 0
+61385595000
Fax 86419 0
Email 86419 0
[email protected]
Contact person for scientific queries
Name 86420 0
Dr Lachlan Miles
Address 86420 0
Department of Anaesthesia
Austin Health
Level 2, Austin Tower
145 Studley Road
HEIDELBERG VIC 3084
Country 86420 0
Australia
Phone 86420 0
+61394965704
Fax 86420 0
Email 86420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.