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Recruiting NCT05407987

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

Phase III Interventional Gynecologic Cancer Anemia Iron-deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ferric derisomaltose, Placebo.
Who it may be relevant to
Registry conditions: Gynecologic Cancer, Anemia, Iron-deficiency. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Ferric derisomaltose
    Ferric Derisomaltose is a solution based iron supplement provided in 100 mg elemental iron/mL. Patients randomized to Iron Therapy Arm will with a bodyweight \<50kg will receive 500mg of Ferric Derisomaltose, and patients with a bodyweight \>50kg will receive 1000mg of Ferric Derisomaltose, to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg. Patients will receive a single infusion between 21 and 90 days preceding surgical intervention.
  • Drug Placebo
    Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.

Primary outcome measures

  • Mean preoperative haemoglobin concentration [Time frame: Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose]
Secondary outcome measures (12)
  • Mean haemoglobin concentration at the time of surgery [Time frame: Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose]
  • Mean postoperative haemoglobin concentration [Time frame: Haemoglobin concentration will be measured at 28 and 60 days after surgery]
  • Assessment of the requirement of postoperative blood transfusion [Time frame: Day 0 to 28 days following surgery]
  • Mean number of blood transfusions [Time frame: Day 0 to 28 days following surgery]
  • Postoperative Quality of Recovery(QoR)-15 questionnaire score [Time frame: Post-operation day 1 (24 hours ± 12 hours following surgery)]
  • Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores [Time frame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative]
  • Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores [Time frame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative]
  • Mean Change in Quality of life measured with the SF-36 scores [Time frame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative]
  • Clinical surgical site infection [Time frame: within 28 days following surgery]
  • Clinical surgical complications [Time frame: within 28 days following surgery]
  • Postoperative length of hospital stay [Time frame: From Surgery date up to 60 days post surgery]
  • Rate of hospital readmission [Time frame: from discharge date to 28 days post surgery]

Eligibility criteria

Inclusion criteria

  • Signed written informed consent prior to initiation of any study specific activities/procedures.
  • Age ≥ 18 years old.
  • 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.
  • The expected time from recruitment to surgery is 28-90 days.
  • Screening haemoglobin less than 120 g/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 (WOCBP) (within 7 days prior to treatment).
  • WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.
  • Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) 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 Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients.
  • Temperature >38C or patient on non-prophylactic antibiotics.
  • Known chronic liver disease or active hepatitis.
  • Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.
  • Alanine transaminase (ALT) or aspartate transaminase (AST) 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 following treatment with study drug or placebo).
  • Unfit for elective surgery.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Arthur J.E. Child Comprehensive Cancer Centre — Calgary

Publications

  • Bisch SP, Woo L, Ljungqvist O, Nelson G. Ferric derisomaltose and Outcomes in the Recovery of Gynecologic oncology: ERAS (Enhanced Recovery After Surgery) (FORGE) - a protocol for a pilot randomised double-blinded parallel-group placebo-controlled study of the feasibility and efficacy of intravenous ferric derisomaltose to correct preoperative iron-deficiency anaemia in patients undergoing gynaeco PMID 37945297

Identifiers

NCT: NCT05407987 · FORGE II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗