Cancer ColonPhase 3PICoCNCT05177484
Perioperative Iron for Colorectal Cancer (PICoC Study)
A Phase 3 study testing oral ferric maltol in people with Cancer Colon, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The PICoC study aims to investigate whether oral ferric maltol given postoperatively offers an improvement in patient and clinician reported outcomes compared to standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Colon
- What is being tested?
- oral ferric maltol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2022to 14 Jul 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18+ years.
- Diagnosed with histologically or radiologically diagnosed colorectal adenocarcinoma.
- Anaemic at point of diagnosis of colorectal adenocarcinoma (Defined as haemoglobin 10g/L below WHO criteria: 120g/L for males and 110g/L for females, to account for a 10% fluctuation in Hb)
- Undergoing surgery for colorectal cancer with curative intent.
- Date of planned surgery is ≥ 14 days from date of planned initiation of recruitment.
- Able (in the investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Who cannot join
- Patients who do not have a histological diagnosis of colorectal adenocarcinoma
- Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.
- Patients with evidence of iron overload or disturbances in utilisation of iron as stated in the product SPC.
- Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected)
- Chemotherapeutic treatment within the last 4 weeks.
- Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established, inflammatory disorders)
Show all 13Show fewer
- Known haematological disease.
- Features necessitating urgent surgery (e.g. obstructive symptoms).
- Previous allergy to intravenous or oral iron or related iron products.
- Patients who are unable to consent.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
- Confirmed liver or lung metastases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Randomised Trial to Assess the Efficacy of Post-Operative Ferric Maltol Vs Standard Care for Anaemia Following Colorectal Cancer Surgery
The PICoC study aims to investigate whether oral ferric maltol given postoperatively offers an improvement in patient and clinician reported outcomes compared to standard care.
Read the detailed description
Colorectal cancer is associated with iron deficiency anaemia in 40-60% of cases. This anaemia 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. However, 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. Our data from previous trials has demonstrated that despite preoperative intravenous iron therapy 75% of patients remain anaemic at the time of their colorectal cancer operation. In addition, our unpublished data has found that around 1/3 of patients treated with preoperative iron therapy develop a recurrence of their anaemia in the first year postoperatively. 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 a response in haemoglobin if given after a colorectal cancer operation. Improving this postoperative anaemia may have important implications for clinician and patient reported outcomes. The Perioperative Iron in Colorectal Cancer (PICoC) trial will run as a feasibility study to assess the proposed design, recruitability and outcome measures. Anaemic colorectal cancer patients treated with preoperative intravenous iron will be randomised in an open label design to receive a course of Ferric maltol (intervention group) or standard care (control group) postoperatively. Secondary outcome measures will focus on 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.
- Conditions
- Cancer Colon
- Being tested
- oral ferric maltol
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral ferric maltolDrug
The intervention group will commence a course of oral ferric maltol provided oral intake has recommenced and the control group will receive standard care. All patients will have blood tests checked again at day 3 and day 5 postoperatively if they remain as an inpatient. If they are found to be anaemic on either of these two blood tests they will, at this stage, enter their allocated treatment pathway. If a patient shows no evidence of anaemia on either day 2, 3 or 5 blood tests they will be withdrawn from the study. Patients will continue treatment according to their randomisation allocation until 12 weeks after the operation, at which point the patient attends a routine surgical outpatient follow-up clinic. During the outpatient visit the participants will undergo their final blood testing and questionnaire completion.
| Study group | Role | What they receive |
|---|---|---|
| Ferric maltol | Experimental | Not described Receives: Drug: oral ferric maltol |
| Standard care | No intervention | Standard post-operative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study
Feasibility measures will include the number of patients:
- Eligible from screening
- excluded and why
- will stay in the study
Measured: 1 year
Secondary outcomes (11)
Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation)
Haemoglobin (Hb) was measured at several timepoints across the study period.
Measured: Diagnosis (Baseline), recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), discharge (5 days post op), and follow up (up to 12 weeks)
Haematinics (Iron Studies)
Iron studies, including total serum iron level, TIBC, transferrin, and transferrin saturation, are essential for diagnosing patients suspected of iron deficiency and overload. Results demonstrated that the Ferric Maltol has improved patents' iron stores.
Measured: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD5 (5 days post op), and follow up (up to 12 weeks)
CRP
We looked at the CRP at the different timepoints
Measured: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), and follow up (up to 12 weeks)
Side Effects to Ferric Maltol Administration
An aspect of the safety and feasibility of the study was the tolerability of ferric maltol amongst post-operative colorectal cancer patients. We recorded any reported symptoms patient experienced as potential side effects.
Measured: 1 year
Adherence to Treatment
Patients adherence to treatment - if they took their tablets. Both arms are not included as the standard care group did not take Ferric Maltol.
Measured: 1 year
Complications
Differences in rates of complications between the two groups.
Measured: 1 year
Mortality
Analysis was using Fisher's exact test due to the small sample size, this is approximately 90-day mortality as patients were followed for approximately 12 weeks.
Measured: 12 weeks
Length of Hospital Stay
Analysing the length of hospital stay of patients in the two groups.
Measured: 1 year
Readmission
Rates of readmission between the two groups.
Measured: 1 year
Allogenic Blood Transfusion
Patients who required blood transfusion during the trial period.
Measured: 1 year
Grip Strength
Assessed the patients grip strength throughout their perioperative journey.
Measured: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), and follow up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start30 May 2022
- Primary completion26 Jan 2024
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cancer ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- Norgine
- Responsible party
- Sponsor
- Investigators
- Nuha Yassin, Principal investigator, The Royal Wolverhampton NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177484
- Sponsor's protocol ID
- 2021GAS120
- Acronym
- PICoC
- Status last verified
- Jan 2026
- First submitted
- 8 Nov 2021
- Last updated
- 30 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomised Trial to Assess the Efficacy of Post-Operative Ferric Maltol Vs Standard Care for Anaemia Following Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT05177484
- Acronym / sponsor ID
- PICoC / 2021GAS120
- Conditions
- Cancer Colon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Collaborators
- Norgine
- Study start
- 30 May 2022 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 19 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PICoC study aims to investigate whether oral ferric maltol given postoperatively offers an improvement in patient and clinician reported outcomes compared to standard care.
Detailed description
Colorectal cancer is associated with iron deficiency anaemia in 40-60% of cases. This anaemia 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. However, 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. Our data from previous trials has demonstrated that despite preoperative intravenous iron therapy 75% of patients remain anaemic at the time of their colorectal cancer operation. In addition, our unpublished data has found that around 1/3 of patients treated with preoperative iron therapy develop a recurrence of their anaemia in the first year postoperatively. 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 a response in haemoglobin if given after a colorectal cancer operation. Improving this postoperative anaemia may have important implications for clinician and patient reported outcomes. The Perioperative Iron in Colorectal Cancer (PICoC) trial will run as a feasibility study to assess the proposed design, recruitability and outcome measures. Anaemic colorectal cancer patients treated with preoperative intravenous iron will be randomised in an open label design to receive a course of Ferric maltol (intervention group) or standard care (control group) postoperatively. Secondary outcome measures will focus on 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric maltol | Experimental | Drug: oral ferric maltol |
| Standard care | No intervention | –Standard post-operative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18+ years.
- Diagnosed with histologically or radiologically diagnosed colorectal adenocarcinoma.
- Anaemic at point of diagnosis of colorectal adenocarcinoma (Defined as haemoglobin 10g/L below WHO criteria: 120g/L for males and 110g/L for females, to account for a 10% fluctuation in Hb)
- Undergoing surgery for colorectal cancer with curative intent.
Key exclusion criteria (13 listed)
- Patients who do not have a histological diagnosis of colorectal adenocarcinoma
- Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.
- Patients with evidence of iron overload or disturbances in utilisation of iron as stated in the product SPC.
- Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected)
- Chemotherapeutic treatment within the last 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral ferric maltolThe intervention group will commence a course of oral ferric maltol provided oral intake has recommenced and the control group will receive standard care. All patients will have blood tests checked again at day 3 and day 5 postoperatively if they remain as an inpatient. If they are found to be anaemic on either of these two blood tests they will, at this stage, enter their allocated treatment pathway. If a patient shows no evidence of anaemia on either day 2, 3 or 5 blood tests they will be withdrawn from the study. Patients will continue treatment according to their randomisation allocation until 12 weeks after the operation, at which point the patient attends a routine surgical outpatient follow-up clinic. During the outpatient visit the participants will undergo their final blood testing and questionnaire completion. | Drug | Ferric maltol |
Primary outcome
The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study
Time frame: 1 year
Feasibility measures will include the number of patients: * Eligible from screening * excluded and why * will stay in the study
11 secondary outcomes
Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation)
Time frame: Diagnosis (Baseline), recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), discharge (5 days post op), and follow up (up to 12 weeks)
Haematinics (Iron Studies)
Time frame: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD5 (5 days post op), and follow up (up to 12 weeks)
CRP
Time frame: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), and follow up (up to 12 weeks)
Side Effects to Ferric Maltol Administration
Time frame: 1 year
Adherence to Treatment
Time frame: 1 year
Complications
Time frame: 1 year
Mortality
Time frame: 12 weeks
Length of Hospital Stay
Time frame: 1 year
Readmission
Time frame: 1 year
Allogenic Blood Transfusion
Time frame: 1 year
Grip Strength
Time frame: Recruitment (at Enrollment), day of surgery (between 2 weeks - 2 months from recruitment), POD2 (2 days post op), POD3 (3 days post op), POD5 (5 days post op), and follow up (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuha Yassin principal investigator
The Royal Wolverhampton NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral ferric maltol in people with Cancer Colon, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.