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

Launched by AHS CANCER CONTROL ALBERTA · Jun 3, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology," is studying a treatment for women with gynecologic cancer who have low iron levels, a condition known as iron-deficiency anemia. The goal is to see if an intravenous (IV) iron treatment called ferric derisomaltose can improve hemoglobin levels (a part of your blood that carries oxygen) before surgery. This is important because many patients with gynecologic cancer experience low iron, and traditional blood transfusions can lead to complications, such as infections and longer hospital stays.

To be eligible for the trial, participants should be at least 18 years old and scheduled for major surgery related to suspected or confirmed gynecologic cancer. They must have low hemoglobin levels and iron levels, and they need to sign consent to join the study. The trial will involve receiving either the iron treatment or a placebo (a substance with no active ingredients) before surgery. Participants can expect careful monitoring and support throughout the process to ensure their safety and well-being. The study is not yet recruiting participants, but it aims to provide valuable information about improving outcomes for women undergoing surgery for gynecologic cancer.

Gender

FEMALE

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.