Perioperative Iron for Colorectal Cancer (PICoC Study) (PICoC)

January 13, 2026 updated by: The Royal Wolverhampton Hospitals NHS Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 In addition, our unpublished data has found that around 1/3 of patients treated with preoperative iron therapy develop a recurrence of their anaemia in the first year postoperatively.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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Wolverhampton, United Kingdom
        • The Royal Wolverhampton Nhs Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ferric maltol
Drug: oral ferric maltol
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.
No Intervention: Standard care
Standard post-operative care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Haemoglobin (Hb) was measured at several timepoints across the study period.
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)
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.
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)
We looked at the CRP at the different timepoints
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
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.
1 year
Adherence to Treatment
Time Frame: 1 year
Patients adherence to treatment - if they took their tablets. Both arms are not included as the standard care group did not take Ferric Maltol.
1 year
Complications
Time Frame: 1 year
Differences in rates of complications between the two groups.
1 year
Mortality
Time Frame: 12 weeks
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.
12 weeks
Length of Hospital Stay
Time Frame: 1 year
Analysing the length of hospital stay of patients in the two groups.
1 year
Readmission
Time Frame: 1 year
Rates of readmission between the two groups.
1 year
Allogenic Blood Transfusion
Time Frame: 1 year
Patients who required blood transfusion during the trial period.
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)
Assessed the patients grip strength throughout their perioperative journey.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Royal Wolverhampton Hospitals NHS Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norgine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nuha Yassin, The Royal Wolverhampton Nhs Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021GAS120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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