NCT05177484CompletedPhase 3
Perioperative Iron for Colorectal Cancer (PICoC Study)
An Open Label Randomised Trial to Assess the Efficacy of Post-Operative Ferric Maltol Vs Standard Care for Anaemia Following Colorectal Cancer Surgery
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 8 Nov 2021
- Start date
- 30 May 2022
- Primary completion date
- 26 Jan 2024
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Diseases
- Colorectal cancer
- NCT number
- NCT05177484
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 40
- From 30 May 2022 to the primary completion date, 26 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gastric, small bowel or colorectal surgery (where ≥50% of stomach or terminal ileum has been resected)
- Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established, inflammatory disorders)
- Features necessitating urgent surgery (e.g. obstructive symptoms).
- Previous allergy to intravenous or oral iron or related iron products.
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
Other illness
- Known haematological disease.
- 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.
Other
- 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.
- Chemotherapeutic treatment within the last 4 weeks.
- Patients who are unable to consent.
- Confirmed liver or lung metastases
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Wolverhampton NHS Trust Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.