PiCoC

• Research type

  Research Study

• Full title

  An Open Label Randomised Trial to Assess the Efficacy of Post-Operative Ferric Maltol Vs Standard Care for Anaemia Following Colorectal Cancer Surgery

• IRAS ID

  1003910

• Contact name

  Nuha Yassin

• Contact email

  nuha.yassin@nhs.net

• Sponsor organisation

  The Royal Wolverhampton NHS Trust

• Eudract number

  2021-006004-32

• ISRCTN Number

  ISRCTN12290106

• Research summary

  Summary of Research
  Colorectal cancer is associated with iron deficiency anaemia in 40-60% of cases which can lead to poorer post-operative outcomes such as higher complication rates, increased length of stay and reduced survival. There has been a recent shift towards the correction of preoperative anaemia in order to optimize perioperative outcomes but despite improvements in preoperative haemoglobin there exists a group of patients who develop worsening or recurrent anaemia in the post-operative period. Without intervention up to 90% of patients in the immediate postoperative period may develop anaemia. This is not unexpected given the peri‐operative blood loss; poor nutritional intake in the postoperative period; and the frequent blood sampling for laboratory tests. Previous trials have demonstrated that despite preoperative intravenous iron therapy 75% of patients remain anaemic at the time of their colorectal cancer operation. Studies have identified that traditional oral ferrous iron supplementation is largely ineffective for the treatment of postoperative anaemia. However, a newer oral iron preparation - ferric maltol (Ferracru) has been found to be better tolerated and more efficacious than ferrous iron. This study aims to evaluate whether the use of iron supplementation in the form of Feraccru could lead to a more sustained or improved response in haemoglobin if given after a colorectal cancer operation. This trial will run as a feasibility study to assess the proposed design. Anaemic colorectal cancer patients treated with preoperative intravenous iron will be randomised in an open label design to receive Ferric maltol (intervention group) or standard care (control group) postoperatively. Outcome measures will include a comparison of change in blood indices, quality of life, allogenic red blood transfusion rates and postoperative complications between groups. Follow up will continue until the first postoperative outpatient visit at approximately 12 weeks following discharge.

  Summary of Results
  Ethics Report – Lay Summary - (PICoC Trial – Perioperative Iron in Colorectal Cancer) - Feasibility Trial

  An Open Label Randomised Trial to Assess the Efficacy of Post-Operative Ferric Maltol Vs Standard Care for Anaemia Following Colorectal Cancer

  The PICoC clinical study looked at whether a medication called ferric maltol, an oral iron supplement, could help patients who were anaemic following surgery for bowel (colorectal) cancer recover more effectively. Anaemia is common in bowel cancer patients and anaemia is known to effect patients’ quality of life.

  In this study, patients were randomly placed into one of two groups: one group received ferric maltol, and the other received standard post-operative care. The treatment lasted for 12 weeks. The study aimed to include 40 patients and successfully enrolled 42, though two patients withdrew before treatment began. Of the 40 who remained in the study until surgery 33 completed the study.

  The study found that ferric maltol was safe and well tolerated, with no increase in side effects compared to standard care. Most patients were able to take the medication as prescribed, with only one patient stopping due to side effects. There were no significant differences in hospital stay, readmissions, or complications between the two groups.

  Importantly, the study showed that ferric maltol may help improve blood iron levels and haemoglobin (the protein that carries oxygen in the blood). While the differences in blood results were not statistically significant due to the small size of the study, these results suggest that patients who received ferric maltol may have better outcomes. More of these patients had returned to normal haemoglobin levels when seen in clinic following their surgery.

  The study also looked at quality of life, asking patients to complete questionnaires at different time points. Patients taking ferric maltol reported improvements in quality-of-life scores compared to those receiving standard care. These improvements were not statistically significant, again due to sample size but were at a level which is important to patients and may be linked to the improvement in their anaemia. There was also a trend toward improved muscle strength in patients taking ferric maltol, as measured by grip strength.

  Overall, this study demonstrated that it is feasible to run a larger trial to test ferric maltol more thoroughly at multiple hospitals. The findings suggest that ferric maltol may be a helpful treatment for anaemia in bowel cancer patients after surgery, potentially improving blood results, muscle strength and patients’ quality of life. The researchers recommend further investigation in a larger study to confirm these promising early results.

• REC name

  Wales REC 2

• REC reference

  22/WA/0035

• Date of REC Opinion

  18 Feb 2022

• REC opinion

  Further Information Favourable Opinion