A trial to assess the efficacy of a new drug versus standard care for anaemia following colorectal cancer surgery

Phase 4

• Conditions: Anaemia with colorectal cancer; Cancer

• Registration Number: ISRCTN12290106
• Lead Sponsor: The Royal Wolverhampton NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-21
• Last Update Posted: 8 July 2024
• Study Completion: 2025-05-29

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study.
2. Male or Female, aged 18+ years.
3. Diagnosed with histologically or radiologically diagnosed colorectal adenocarcinoma.
4. Anaemic at point of diagnosis of colorectal adenocarcinoma (Defined as haemoglobin 10 g/L below WHO criteria: 120 g/L for males and 110 g/L for females, to account for a 10% fluctuation in Hb)
5. Undergoing surgery for colorectal cancer with curative intent.
6. Date of planned surgery is =14 days from date of planned initiation of recruitment.
7. Able (in the investigators opinion) and willing to comply with all study requirements.
8. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria

1. Patients with mental health issues or learning disabilities resulting in their inability to consent to the study
2. Patients who do not have a histological diagnosis of colorectal adenocarcinoma
3. Female participants who are pregnant, lactating or planning a pregnancy during the course of the study.
4. Patients with evidence of iron overload or disturbances in utilisation of iron as stated in the product SPC.
5. Previous gastric, small bowel or colorectal surgery (where =50% of stomach or terminal ileum has been resected)
6. Chemotherapeutic treatment within the last 4 weeks.
7. Known previous anaemia not attributable to colorectal carcinoma (i.e. anaemia in patients with well established, inflammatory disorders)
8. Known haematological disease.
9. Features necessitating urgent surgery (e.g. obstructive symptoms).
10. Previous allergy to intravenous or oral iron or related iron products.
11. Patients who are unable to consent.
12. 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.
13. Participants who have participated in another research study involving an investigational product in the past 12 weeks
14. Confirmed liver or lung metastases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility outcomes:<br>1. Eligible patients from screening - recorded as the number of eligible patients for the study until the end of recruitment at 18 months<br>2. Study exclusion - patients who are below the age of 18, those on chemoradiotherapy prior to surgery and other potential causes for anaemia apart from the colorectal cancer<br>3. Acceptability of recruitment - Recruitment rate recorded as the number of eligible participant who consent to participate in the study by 18 months<br>4. Study retention - Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 21 months

Secondary Outcome Measures

Name	Time	Method
Measured using patient records unless otherwise noted:<br>1. Levels of haemoglobin and haematinic markers (full blood count, ferritin, iron, transferrin, and transferrin saturation). Immunological and metabolomic markers will also be assessed. These will be measured at a point preoperatively before intravenous iron treatment, on the day of surgery and at defined time points postoperatively during the administration of oral ferric maltol or during standard care<br>2. Side-effects and reactions to ferric maltol administration<br>3. Peri- and post-operative morbidity and mortality<br>4. Post-operative complications<br>5. Post-operative length of stay <br>6. Post-operative allogenic blood transfusion.<br>7. Quality of life as determined by the SF36, EQ-5D and FACT-An questionnaires.