Using ferric derisomaltose to improve recovery in gynecologic cancer 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

This study is testing if an iron treatment can help women with gynecologic cancer surgery recover better by improving their iron levels and reducing the need for blood transfusions.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: AHS Cancer Control Alberta (Academic / other)
• Locations: 1 site (Calgary, Alberta)
• Trial ID: NCT05407987 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of intravenous ferric derisomaltose in correcting pre-operative iron-deficiency anemia in patients undergoing major surgery for gynecologic cancer. It is a randomized, double-blinded study comparing the treatment to a placebo. The goal is to improve pre-operative hemoglobin levels and reduce the need for blood transfusions, which can carry risks and complications. The trial aims to enroll patients who meet specific criteria related to their surgery and iron levels.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for elective major surgery due to suspected or proven gynecologic malignancy and have pre-operative iron-deficiency anemia.

Not a fit: Patients who do not have iron-deficiency anemia or are not undergoing major gynecologic surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve surgical outcomes and recovery for patients with gynecologic cancer by reducing the need for blood transfusions.

How similar studies have performed: Previous studies have shown that pre-operative intravenous iron formulations can effectively increase hemoglobin levels and decrease transfusion rates in surgical patients, suggesting a promising approach.

Eligibility criteria

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.

Where this trial is running

Calgary, Alberta

• Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada (Recruiting)

Study contacts

• Study coordinator: Steven Bisch, MD

Conditions Gynecologic Cancer; Anemia; Iron-deficiency