Clinical trial NCT05407987: Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
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
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gynecologic Cancer
Anemia
Iron-deficiency
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent prior to initiation of any study specific activities/procedures.
2. Age ≥ 18 years old.
3. 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.
   3. The expected time from recruitment to surgery is 28-90 days.
4. Screening haemoglobin less than 120 g/L and transferrin saturation (TSAT) \<20%.
5. Randomization and administration of study infusion a minimum of 21 days and maximum 90 days before planned operation.
6. Negative pregnancy test for women of childbearing potential (WOCBP) (within 7 days prior to treatment).
7. WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.
8. Laboratory data used for determination of eligibility (Hemoglobin and Transferrin saturation) 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 Ferric derisomaltose/iron isomaltoside (Monoferric®) or its excipients.
4. Temperature \>38C or patient on non-prophylactic antibiotics.
5. Known chronic liver disease or active hepatitis.
6. Received erythropoietin or IV iron therapy within previous 12 weeks prior to planned study drug treatment.
7. Alanine transaminase (ALT) or aspartate transaminase (AST) 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 following treatment with study drug or placebo).
9. Unfit for elective surgery.
10. 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.

Primary outcomes:
measure: Mean preoperative haemoglobin concentration
timeFrame: Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose
Secondary outcomes:
measure: Mean haemoglobin concentration at the time of surgery
timeFrame: Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose
measure: Mean postoperative haemoglobin concentration
timeFrame: Haemoglobin concentration will be measured at 28 and 60 days after surgery
measure: Assessment of the requirement of postoperative blood transfusion
timeFrame: Day 0 to 28 days following surgery
measure: Mean number of blood transfusions
timeFrame: Day 0 to 28 days following surgery
measure: Postoperative Quality of Recovery(QoR)-15 questionnaire score
timeFrame: Post-operation day 1 (24 hours ± 12 hours following surgery)
measure: Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores
timeFrame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
measure: Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores
timeFrame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
measure: Mean Change in Quality of life measured with the SF-36 scores
timeFrame: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative
measure: Clinical surgical site infection
timeFrame: within 28 days following surgery
measure: Clinical surgical complications
timeFrame: within 28 days following surgery
measure: Postoperative length of hospital stay
timeFrame: From Surgery date up to 60 days post surgery
measure: Rate of hospital readmission
timeFrame: from discharge date to 28 days post surgery
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
Study officials:
References: