Iron infusion in iron-deficient patients undergoing surgery for colorectal cancer who are anaemic versus not anaemic in order to improve physical fitness as determined by exercise testing and a quality of life questionnaire.

Phase 4

Recruiting

• Conditions: Colorectal Cancer; Iron deficiency; Anaemia; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Anaesthesiology - Other anaesthesiology; Blood - Anaemia

• Registration Number: ACTRN12616001219471
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patients 18 years of age and older
2. Patients with histologically confirmed colorectal cancer presenting to Peter MacCallum Cancer Centre, or Epworth Hospital (Richmond and Eastern campuses).
3. Ferritin <100mcg/l or 100-300mcg/L and TSAT<20%
4. Normal Serum Vitamin B12 and Folate levels
5. Normal red cell folate and B12 levels
6. Patients planned for surgery colorectal surgery

Exclusion Criteria

1. Hb (>130mg/dL male, or >120mg/dL female) & (either one of: Ferritin >300mcg/l, or Ferritin >100mcg/l and TSAT >20%)
2. Marked Iron deficiency anaemia precluding randomization: Hb < 110 mg/dL & Ferritin <20 mcg/l
3. Iron therapy contraindicated
4. Treatment with iron therapy or blood transfusion in the previous 12 weeks
5. Presentation for neoadjuvant CRT or Surgery within the study period
6. Patients with a known haematological abnormality (such as haemochromatosis or thalassemia, TSAT >50%)
7. Liver disease where ALT is above 3 times the upper limit of the normal range
8. Patients with a history of acquired iron overload or iron storage disorders
9. Previous hypersensitivity or allergic reactions to parentral (polymaltose/carboxymaltose) iron preparations
10. Patients unable to give informed consent
11. Physical disability preventing CPX, or contraindication in local CPX policy (such as angina at rest)
12. Patients included in other clinical trials that involve the administration of iron therapy
13. Blood transfusion in previous three months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess if the preoperative functional status (as measured by CPX) of anaemic and/or iron deficient colorectal cancer patients will be improved following an intravenous infusion of FCM. The primary endpoint is the change in VO2peak measured by the CPX, from baseline CPX (Day 0) to CPX test #2 (Day 14) following a transfusion of FCM.[The primary endpoint is the change in VO2peak measured by the CPX, from baseline CPX (Day 0) to CPX test #2 (Day 14) following a transfusion of FCM.]