Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS

Surgery Clinical Trial

— FORGE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05467319
• Other study ID #: FORGEII
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 30, 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Alberta Health Services, Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Iron deficiency has been reported in up to 35% of patients with a gynecologic malignancy. These patients often require surgical intervention to determine the stage and to treat their illness. Blood transfusions occur in approximately 14% of these surgeries and carry immediate and long-term risks, including surgical site infection, cancer recurrence, and increased surgical length of stay. Intravenous iron formulations have the potential to rapidly correct anemia in patients with gynecologic malignancy and potentially decrease blood transfusion and complications following surgery. This prospective, randomized, placebo-controlled, double blind 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. The primary outcome is to assess the effectiveness of this formulation on pre-operative hemoglobin, and the feasibility of a larger, outcomes based, study in the future. Exploratory outcomes are to assess the effect of preoperative intravenous iron on surgical length of stay, complications, and patient-reported quality of life.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. At least 18 years of age and signed written informed consent

2. 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[19].

3. The expected time from recruitment to surgery is at least 28 days.

3. Screening haemoglobin less than 120g/L and transferrin saturation (TSAT) <20%

4. Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.

5. Negative pregnancy test for women of childbearing potential (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment (if applicable)

6. Laboratory data used for determination of eligibility 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 FDI or its excipients

4. Temperature >38 C or patient on non-prophylactic antibiotics

5. Known chronic liver disease or active hepatitis

6. Received erythropoietin or IV iron therapy in previous 12 weeks

7. If LFT's are ordered, either clinically indicated or for chemotherapy, and screening alanine transaminase (ALT) or aspartate transaminase (AST) is 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)

9. Unfit for elective surgery

10. Pregnancy or lactation

11. Unable to fully comprehend and/or perform study procedures

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Gynecologic Cancer
• Surgery

Intervention

Drug:
• Ferric Derisomaltose Injection
1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion
• Normal saline
100 mL of 0.9% normal saline (w/v) by intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Health Services, Calgary	Pharmacosmos A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative hemoglobin level	Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.	0 to 3 days prior to planned surgical intervention