Perioperative Iron for Colorectal Cancer (PICoC Study) (NCT05177484) | Clinical Trial Compass
CompletedPhase 3
Perioperative Iron for Colorectal Cancer (PICoC Study)
United Kingdom40 participantsStarted 2022-05-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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. …
What they're measuring
1
The Feasibility of Running the Study, to See if it Could be Run as a Large Multi-centre Study
Timeframe: 1 year
Trial details
NCT IDNCT05177484
SponsorThe Royal Wolverhampton Hospitals NHS Trust