Perioperative Iron for Colorectal Cancer (PICoC Study)

The Royal Wolverhampton Hospitals NHS Trust40 enrolled

Overview

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.

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 In addition, our unpublished data has found that around 1/3 of patients treated with preoperative iron therapy develop a recurrence of their anaemia in the first year postoperatively.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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer Colon

Interventions

oral ferric maltolDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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

Haemoglobin (Hb) was measured at several timepoints across the study period.

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)

Haematinics (Iron Studies)

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.

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)

CRP

We looked at the CRP at the different timepoints

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)

Side Effects to Ferric Maltol Administration

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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