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

AHS Cancer Control Alberta

Status and phase: Not yet enrolling; Phase 3

Conditions: Anemia; Iron-deficiency; Gynecologic Cancer

Treatments: Drug: Ferric derisomaltose; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05407987

FORGE II

Details and patient eligibility

About

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.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

11. 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.

12. Cervical cancer with a clinical stage of 2A or greater.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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82 participants in 2 patient groups, including a placebo group

Iron Therapy Arm

Experimental group

Description:

500 or 1000mg of IV Ferric Derisomaltose in 100mL normal saline will be administered intravenously over 1 hour. Participants with bodyweight \<50kg will receive 500mg, participants with bodyweight \>50kg will receive 1000mg to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg bodyweight.

Treatment:

Drug: Ferric derisomaltose

Placebo Arm

Placebo Comparator group

Description:

100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.

Treatment:

Drug: Placebo