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| Name | Class |
|---|---|
| Norgine | INDUSTRY |
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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 In addition, our unpublished data has found that around 1/3 of patients treated with preoperative iron therapy develop a recurrence of their anaemia in the first year postoperatively.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric maltol | Experimental |
| |
| Standard care | No Intervention | Standard post-operative care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuha Yassin | The Royal Wolverhampton NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Wolverhampton NHS Trust | Wolverhampton | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Maltol | oral ferric maltol: 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. |
| FG001 | Standard Care | Standard post-operative care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Colorectal cancer patients who were anaemic at diagnosis of their cancer.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Maltol | oral ferric maltol: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| A total of 42 patients were recruited to the study. There were 2 patients who were withdrawn prior to randomisation. Of those 40 patients randomised 32 patients remained in the study to analysis, this was 80%. | Posted | Number | participants | 1 year |
|
Prior to randomisation, following discharge, during admission, post-operative. Through to study completion, over 19 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferric Maltol | oral ferric maltol: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital stay | Gastrointestinal disorders | Systematic Assessment | Prolonged Hospital Stay for post-operative Ileus, acute kidney injury, supraventricular tachycardia and pneumonia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delirium | Investigations | Systematic Assessment | Delirium following discharged - did not require admission and settled. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Group Research Sponsorship Manager | Royal Wolverhampton NHS Trust | 01902 | 695065 | rwh-tr.sponsorshipofresearch@nhs.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2023 | Jul 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C062088 | ferric maltol |
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|
| 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. | 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 | 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. | 1 year |
| Adherence to Treatment | Patients adherence to treatment - if they took their tablets. Both arms are not included as the standard care group did not take Ferric Maltol. | 1 year |
| Complications | Differences in rates of complications between the two groups. | 1 year |
| Mortality | Analysis was using Fisher's exact test due to the small sample size, this is approximately 90-day mortality as patients were followed for approximately 12 weeks. | 12 weeks |
| Length of Hospital Stay | Analysing the length of hospital stay of patients in the two groups. | 1 year |
| Readmission | Rates of readmission between the two groups. | 1 year |
| Allogenic Blood Transfusion | Patients who required blood transfusion during the trial period. | 1 year |
| Grip Strength | Assessed the patients grip strength throughout their perioperative journey. | 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 (12 weeks) |
| Withdrawn as not given standard care, given IV iron |
|
| BG001 | Standard Care | Standard post-operative care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Standard Care | Standard post-operative care |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | g/l | 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) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmol/l | 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) |
|
|
|
| Secondary | CRP | We looked at the CRP at the different timepoints | Posted | Mean | Standard Deviation | mg/dl | 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) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Adherence to Treatment | Patients adherence to treatment - if they took their tablets. Both arms are not included as the standard care group did not take Ferric Maltol. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Complications | Differences in rates of complications between the two groups. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Mortality | Analysis was using Fisher's exact test due to the small sample size, this is approximately 90-day mortality as patients were followed for approximately 12 weeks. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Length of Hospital Stay | Analysing the length of hospital stay of patients in the two groups. | Posted | Mean | Standard Deviation | Days | 1 year |
|
|
|
| Secondary | Readmission | Rates of readmission between the two groups. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Allogenic Blood Transfusion | Patients who required blood transfusion during the trial period. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Grip Strength | Assessed the patients grip strength throughout their perioperative journey. | Posted | Mean | Standard Deviation | kg | 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 (12 weeks) |
|
|
|
| 1 |
| 16 |
| 6 |
| 16 |
| 4 |
| 16 |
| EG001 | Standard Care | Standard post-operative care | 0 | 18 | 4 | 18 | 3 | 18 |
|
| Hospital stay | Infections and infestations | Systematic Assessment | Prolonged Hospital Stay with wound infection |
|
| Hospital stay | Cardiac disorders | Systematic Assessment | Prolonged hospital stay and unexpected ITU admission with pulmonary embolism and pneumonia |
|
| Readmission | Infections and infestations | Systematic Assessment | Readmission for wound infection |
|
| Hospital stay | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Prolonged Hospital Stay including treatment for pneumonia. |
|
| Hospital stay | Gastrointestinal disorders | Systematic Assessment | Prolonged Hospital stay for post-operative Ileus and acute kidney injury |
|
| Readmission | Blood and lymphatic system disorders | Systematic Assessment | Readmission and blood transfusion for bleeding per rectum. |
|
| Hospital stay | Gastrointestinal disorders | Systematic Assessment | Prolonged Hospital stay for anastomotic bleeding with return to theatre resulting in Ileostomy. |
|
| Anastomotic Leak | Gastrointestinal disorders | Systematic Assessment | Anastomotic Leak which resulted in death. |
|
| Readmission | Gastrointestinal disorders | Systematic Assessment | Readmission with pain found to have an ischaemic anastomotic stricture. |
|
|
| Bleed | Surgical and medical procedures | Systematic Assessment | Port site bleed managed conservatively. |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment | Intermittent Vertigo |
|
| Oedema | Surgical and medical procedures | Systematic Assessment | Oedema in lower limbs following surgery. During admission also had a fall with minor head injury and urinary tract infection |
|
| Infection | Infections and infestations | Systematic Assessment | Wound infection treated by GP with oral antibiotics. |
|
| Side effect of Ferric Maltol | Product Issues | Systematic Assessment | Side effects of Ferric Maltol. Patient reported medication not tolerated due to nausea, diarrhoea, constipation, abdominal pain and headache. |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Rash developed during anaesthetic |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| AHb at Day of Surgery |
|
| Hb on POD2 |
|
| Hb on POD3 |
|
| Hb on POD5 |
|
| Hb on Discharge |
|
| Hb Follow Up |
|
| Iron on POD5 |
|
| Iron follow up |
|
| Transferrin at recruitment |
|
| Transferrin at day of surgery |
|
| Transferrin on POD5 |
|
| Transferrin follow up |
|
| T.Sats at recruitment |
|
| T.Sats at day of surgery |
|
| T.Sats on POD5 |
|
| T.Sats follow up |
|
| TIBC at recruitment |
|
| TIBC at day of surgery |
|
| TIBC on POD5 |
|
| TIBC follow up |
|
| POD2 |
|
| POD3 |
|
| POD5 |
|
| Follow up |
|
| Few of tablets taken |
|
| Post-operative Transfusion (Following Discharge) |
|
| POD2 |
|
| POD3 |
|
| POD5 |
|
| Follow up |
|