search
Back to results

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

Primary Purpose

Gynecologic Cancer, Anemia, Iron Deficiency, Surgery

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ferric Derisomaltose Injection
Normal saline
Sponsored by
Alberta Health Services, Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Cancer focused on measuring Ferric derisomaltose, iron isomaltoside, intravenous iron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Ferric derisomaltose

    Placebo

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Preoperative hemoglobin level
    Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2022
    Last Updated
    July 19, 2022
    Sponsor
    Alberta Health Services, Calgary
    Collaborators
    Pharmacosmos A/S
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05467319
    Brief Title
    Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Alberta Health Services, Calgary
    Collaborators
    Pharmacosmos A/S

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gynecologic Cancer, Anemia, Iron Deficiency, Surgery
    Keywords
    Ferric derisomaltose, iron isomaltoside, intravenous iron

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel groups, randomized placebo-controlled, double blind
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Intravenous treatment will be prepared by an unblinded provider and placed in opaque bags/tubing to blind the patient, administrator of the medication, and subsequent outcome assessors and care providers.
    Allocation
    Randomized
    Enrollment
    82 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ferric derisomaltose
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    100mL of normal saline will be administered 21-90 days prior to planned surgery for gynecologic malignancy as a single dose.
    Intervention Type
    Drug
    Intervention Name(s)
    Ferric Derisomaltose Injection
    Other Intervention Name(s)
    iron isomaltoside, Monoferric, Monofer
    Intervention Description
    1000mg of ferric derisomaltose in 100mL of normal saline by intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Intervention Description
    100 mL of 0.9% normal saline (w/v) by intravenous infusion
    Primary Outcome Measure Information:
    Title
    Preoperative hemoglobin level
    Description
    Hemoglobin measured, in g/L, following intervention prior to planned gynecologic surgery.
    Time Frame
    0 to 3 days prior to planned surgical intervention

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age and signed written informed consent Patients undergoing elective major surgery on the gynecologic oncology service with the following criteria will be considered for inclusion: The indication for the operation may be for suspected or proven gynecologic malignancy. 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]. The expected time from recruitment to surgery is at least 28 days. Screening haemoglobin less than 120g/L and transferrin saturation (TSAT) <20% Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation. 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) Laboratory data used for determination of eligibility at the baseline visit must not be older than 4 weeks. Exclusion Criteria: Known history of acquired iron overload, or family history of haemochromatosis or thalassemia, or TSAT >50% Known alternative cause for anemia (e.g. B12 or folate deficiency, or haemoglobinopathy) Known hypersensitivity to FDI or its excipients Temperature >38 C or patient on non-prophylactic antibiotics Known chronic liver disease or active hepatitis Received erythropoietin or IV iron therapy in previous 12 weeks 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 Immunosuppressive therapy (for solid organ transplant), or renal dialysis (current, or planned within next 12 months) Unfit for elective surgery Pregnancy or lactation Unable to fully comprehend and/or perform study procedures Cervical cancer with a clinical stage of 2A or greater.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs