Status:
RECRUITING
Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Gynecologic Cancer
Anemia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Iron deficiency has been reported in approximately 35% of patients with a gynecologic malignancy. Blood transfusions are known to be immunosuppressive and carry immediate and long-term risks. Pre-oper...
Eligibility Criteria
Inclusion
- Signed written informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years old.
- Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion:
- The indication for the operation may be for suspected or proven gynecologic malignancy.
- Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1.
- The expected time from recruitment to surgery is 28-90 days.
- Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) \<20%.
- Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.
- Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment).
- WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.
- Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) at the baseline visit must not be older than 4 weeks.
Exclusion
- Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT \>50%.
- Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy).
- Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients.
- Temperature \>38C or patient on non-prophylactic antibiotics.
- Known chronic liver disease or active hepatitis.
- Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.
- Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range.
- Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo).
- Unfit for elective surgery.
- Pregnancy or lactation.
- 1\. Unable to fully comprehend and/or perform study procedures and patients with psychiatric illness/social situations/substance abuse that would limit compliance with study requirements.
- 11\. Cervical cancer with a clinical stage of 2A or greater.
Key Trial Info
Start Date :
April 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05407987
Start Date
April 8 2025
End Date
December 30 2026
Last Update
April 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2