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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат Placebo
  Patients randomized to the Placebo arm will receive 100mg of normal saline over 1 hour.

Первичные конечные точки

• Mean preoperative haemoglobin concentration [Срок оценки: Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Arthur J.E. Child Comprehensive Cancer Centre — Calgary

Публикации

• 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

Идентификаторы

NCT: NCT05407987 · FORGE II

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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