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

NCT ID: NCT05467319

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-12-31

Brief 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.

Conditions

Gynecologic Cancer; Anemia, Iron Deficiency; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ferric derisomaltose

1000mg of intravenous Ferric derisomaltose/Iron isomaltoside in 100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.

Group Type: EXPERIMENTAL

Ferric Derisomaltose Injection

Intervention Type: DRUG

1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion

Placebo

100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

100 mL of 0.9% normal saline (w/v) by intravenous infusion

Interventions

Ferric Derisomaltose Injection

1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion

Intervention Type: DRUG

Normal saline

100 mL of 0.9% normal saline (w/v) by intravenous infusion

Intervention Type: DRUG

Other Intervention Names

iron isomaltoside; Monoferric; Monofer

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pharmacosmos A/S

INDUSTRY

Sponsor Role: collaborator

Alberta Health Services, Calgary

OTHER

Sponsor Role: lead

Responsible Party

Steven Bisch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FORGEII

Identifier Type: -

Identifier Source: org_study_id