{
  "abstract": "Introduction Perioperative anaemia in colorectal cancer(CRC) can result in increased complications; longer hospital stays and increased morbidity and mortality. As a result, there has been a focus on correcting preoperative anaemia. However, despite improvements in preoperative anaemia management many patients develop worsening or recurrent anaemia postoperatively. Traditional ferrous sulphate lacks efficacy data and is associated with a pronounced side effect profile. A newer preparation, ferric maltol, may be better tolerated and more efficacious.Methods Our primary outcomes were feasibility including eligibility, acceptability and retention when treating postoperative anaemia with ferric maltol. Secondary outcomes included blood indices and quality of life(QoL). To investigate QoL we used Fact-An, SF-36 and EQ-5D-5L, analysing scores and minimal clinically important difference(MCID). Forty anaemic patients were recruited preoperatively and randomised in an open label design to receive ferric maltol or standard care (SC) following surgery. Patients were followed up for 12 weeks.Results We demonstrated feasibility. Recruitment was acceptable with 85.7% of eligible patients recruited and retention was 82.5%. Haemoglobin(Hb) rose 30.67g/dl(20.50) vs 22.56g/dl(14.51) with SC(p=0.194) demonstrating a signal of efficacy. Ferric maltol significantly improved haematinics at 12 weeks, with transferrin 2.34(0.43) vs 2.71(0.55), p = 0.046 and total iron binding capacity 58.65%(10.77) vs 67.81%(13.71), p = 0.046. Serum iron was higher with ferric maltol, 15.69 mmol/(8.93) vs 12.97 mmol/l(6.66), but this difference was not significant(p = 0.334). These results are indicators of iron repletion in patients treated with ferric maltol.QoL(Fact-An) improved with ferric maltol and decreased with SC. Whilst these results were not significant the change in QoL exceeded the MCID demonstrating a strong signal of efficacy. There was a significant positive correlation between the mean Hb and mean QoL at each time point for Fact-An total score, p=0.046 and Fact-G, p=0.039, indicating improved QoL is related to Hb. We also show a signal of efficacy in improved grip strength with ferric maltol, 0.625kg(4.86) vs 0.022kg(2.503), p=0.6582. There were no safety concerns, with no difference in complication rates, p>0.999.Conclusion We demonstrate a randomised control trial(RCT) of ferric maltol for postoperative anaemia in CRC is feasible and safe. Ferric maltol provided evidence of iron repletion. Preliminary signals for improved Hb, QoL and grip strength were observed, but require confirmation in a future, definitive RCT, for which this study provides essential design parameters. A multi-arm, multi-centre RCT involving ferric maltol to investigate management of perioperative anaemia in CRC patients is now recommended.",
  "authors": [
    {
      "affiliations": [
        "University of Wolverhampton, Wolverhampton, United Kingdom",
        "University Hospital Birmingham NHS Foundation Trust, Birmingham, West Midlands"
      ],
      "name": "Alexandra Marley"
    },
    {
      "affiliations": [
        "Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire"
      ],
      "name": "Edward Dickson"
    },
    {
      "affiliations": [
        "Royal Wolverhampton NHS Trust, Wolverhampton, West Midlands"
      ],
      "name": "Blessing Oduh"
    },
    {
      "affiliations": [
        "University of Wolverhampton, Wolverhampton, United Kingdom"
      ],
      "name": "Hafid Al-Hassi"
    },
    {
      "affiliations": [
        "University of Nottingham, Nottingham, Nottinghamshire"
      ],
      "name": "Austin Acheson"
    },
    {
      "affiliations": [
        "University Hospital Birmingham NHS Foundation Trust, Birmingham, West Midlands"
      ],
      "name": "Nuha Yassin"
    },
    {
      "affiliations": [
        "University of Wolverhampton, Wolverhampton, United Kingdom",
        "Royal Wolverhampton NHS Trust, Wolverhampton, West Midlands"
      ],
      "name": "Matthew J Brookes"
    }
  ],
  "title": "FP5 Efficacy of ferric maltol for anaemia treatment and improvement in quality of life following colorectal cancer surgery: open-label randomised trial (PiCoC trial)",
  "uid": "66fc1944-d969-50bf-8854-00fd308685c3"
}