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RECRUITING

NCT05407987

PHASE3

Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Sponsor: AHS Cancer Control Alberta

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-08

Completion Date

2026-12-30

Last Updated

2025-04-25

Healthy Volunteers

Conditions

Gynecologic Cancer Anemia Iron-deficiency

Interventions

DRUG

Ferric derisomaltose

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.

DRUG

Placebo

Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.

Inclusion Criteria: 1. Signed written informed consent prior to initiation of any study specific activities/procedures. 2. Age ≥ 18 years old. 3. Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion: 1. The indication for the operation may be for suspected or proven gynecologic malignancy. 2. Major surgery is defined as an operation of a duration of 1 hour or greater, with an Aletti complexity score of at least 1. 3. The expected time from recruitment to surgery is 28-90 days. 4. Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) \<20%. 5. Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation. 6. Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment). 7. WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment. 8. Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) at the baseline visit must not be older than 4 weeks. Exclusion Criteria: 1. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT \>50%. 2. Known alternative cause for anemia (e.g., B12 or folate deficiency, or haemoglobinopathy). 3. Known hypersensitivity to Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients. 4. Temperature \>38C or patient on non-prophylactic antibiotics. 5. Known chronic liver disease or active hepatitis. 6. Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment. 7. Alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal (ULN) range. 8. Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months following treatment with study drug or placebo). 9. Unfit for elective surgery. 10. 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.

Locations (1)

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada