Phase 3
N=40
Perioperative Iron for Colorectal Cancer (PICoC Study)
Cancer Colon
Bottom Line
View on ClinicalTrials.gov: NCT05177484 ↗Enrolled (actual)
40
Serious AEs
29.4%
Results posted
Sep 2025
Primary outcome: Primary: The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study — 16; 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- oral ferric maltol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study |
16; 18 | — |
| SECONDARY Levels of Haemoglobin and Haematinic Markers (Full Blood Count, Ferritin, Iron, Transferrin, and Transferrin Saturation) |
87; 93.55; 106.4; 105; 116.7; 116.2 | — |
| SECONDARY Haematinics (Iron Studies) |
8.445; 6.86; 13.68; 11.52; 6.938; 7.328 | — |
| SECONDARY CRP |
13.29; 11.8; 11.9; 12.55; 137.8; 145.85 | — |
| SECONDARY Side Effects to Ferric Maltol Administration |
10; 11; 5; 6 | — |
| SECONDARY Adherence to Treatment |
11; 2; 1; 1 | — |
| SECONDARY Complications |
8; 9; 7; 8 | — |
| SECONDARY Mortality |
1; 0; 14; 16 | — |
| SECONDARY Length of Hospital Stay |
7.133; 7.333 | — |
| SECONDARY Readmission |
2; 1; 14; 16 | — |
| SECONDARY Allogenic Blood Transfusion |
3; 1; 1; 1; 0; 1 | — |
| SECONDARY Grip Strength |
23.0868421; 23.6342105; 23.2763158; 24.84; 20; 21.55 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05177484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.