Perioperative Iron for Colorectal Cancer (PICoC Study)

NCT05177484 | Completed Phase 3 Results DMC

• 1 other identifier: 2021GAS120
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Colon

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (11)

• Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation)

  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)

  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

  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

  1 year

• Adherence to Treatment

  1 year

Study Arms (2)

Ferric maltol

EXPERIMENTAL

Drug: oral ferric maltol

Standard care

NO INTERVENTION

Standard post-operative care

Interventions

oral ferric maltol DRUG

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 If a patient shows no evidence of anaemia on either day 2, 3 or 5 blood tests they will be withdrawn from the study.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.

Ferric maltol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• Norgine: collaborator

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

ferric maltol

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Group Research Sponsorship Manager
• Organization: Royal Wolverhampton NHS Trust

rwh-tr.sponsorshipofresearch@nhs.net

01902

Study Officials

• Nuha Yassin

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: January 4, 2022
• Study Start: May 30, 2022
• Primary Completion: January 26, 2024
• Study Completion: July 14, 2025
• Last Updated: January 30, 2026
• Results First Posted: September 19, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)