Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
Feasibility and Efficacy of Intravenous Ferric Derisomaltose to Correct Pre-operative Iron-deficiency Anemia in Patients Undergoing Gynecologic Oncology Surgery: a Pilot Randomized Double Blinded Parallel Group Placebo-controlled Study
AHS Cancer Control Alberta
82 participants
Apr 8, 2025
INTERVENTIONAL
Conditions
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-operative blood transfusion in gynecologic oncology patients is associated with higher rates of surgical site infection, length of stay, composite morbidity, cancer recurrence, and mortality. Pre-operative intravenous iron formulations have been shown in benign gynecology and other surgical specialities to increase pre-operative hemoglobin and decrease post-operative transfusion rates. This is a randomized double-blinded clinical trial evaluating the effects of treating patients undergoing gynecologic oncology surgery with intravenous ferric derisomaltose to correct pre-operative iron-deficiency anemia. The study aims to assess the effectiveness of preoperative ferric derisomaltose/iron isomaltoside compared to placebo in correcting preoperative hemoglobin in patients undergoing surgery for gynecologic malignancy.
Eligibility
Inclusion Criteria10
- Signed written informed consent prior to initiation of any study specific activities/procedures.
- Age ≥ 18 years old.
- 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 Criteria12
- 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.
- \. 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.
- \. Cervical cancer with a clinical stage of 2A or greater.
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Interventions
Ferric Derisomaltose is a solution based iron supplement provided in 100 mg elemental iron/mL. Patients randomized to Iron Therapy Arm will with a bodyweight \<50kg will receive 500mg of Ferric Derisomaltose, and patients with a bodyweight \>50kg will receive 1000mg of Ferric Derisomaltose, to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg. Patients will receive a single infusion between 21 and 90 days preceding surgical intervention.
Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05407987