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

Studies

Study First Submitted Date 2022-06-01
Study First Posted Date 2022-06-07
Last Update Posted Date 2023-07-21
Start Month Year February 1, 2024
Primary Completion Month Year October 30, 2025
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-07-21

Facilities

Sequence: 200441298
Name Tom Baker Cancer Centre
City Calgary
State Alberta
Zip T2N 4N2
Country Canada

Facility Contacts

Sequence: 28156344 Sequence: 28156345
Facility Id 200441298 Facility Id 200441298
Contact Type primary Contact Type backup
Name Steven Bisch, MD Name Kelsey Meyer
Email Steven.Bisch@ahs.ca Email Kelsey.Meyer@ahs.ca
Phone 403-521-3721

Conditions

Sequence: 52274213 Sequence: 52274214 Sequence: 52274215
Name Gynecologic Cancer Name Anemia Name Iron-deficiency
Downcase Name gynecologic cancer Downcase Name anemia Downcase Name iron-deficiency

Id Information

Sequence: 40233189
Id Source org_study_id
Id Value FORGE II

Countries

Sequence: 42649724
Name Canada
Removed False

Design Groups

Sequence: 55708158 Sequence: 55708159
Group Type Experimental Group Type Placebo Comparator
Title Iron Therapy Arm Title Placebo Arm
Description 1000mg of IV Ferric Derisomaltose in 500mL normal saline will be administered intravenously over 1 hour. Description 500mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.

Interventions

Sequence: 52586509 Sequence: 52586510
Intervention Type Drug Intervention Type Drug
Name Ferric derisomaltose Name Placebo
Description Ferric Derisomaltose is a solution based iron supplement provided in 100 mg elemental iron/mL. Patients randomized to Iron Therapy Arm will receive 500 MG in 5 ML Injection of Ferric derisomaltose at between 21 and 90 days preceding surgical intervention. Description normal saline solution

Design Outcomes

Sequence: 177758481 Sequence: 177758482 Sequence: 177758483 Sequence: 177758484 Sequence: 177758485 Sequence: 177758486 Sequence: 177758487 Sequence: 177758488 Sequence: 177758489 Sequence: 177758490 Sequence: 177758491 Sequence: 177758492 Sequence: 177758493
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Mean preoperative haemoglobin concentration Measure Mean haemoglobin concentration at the time of surgery Measure Mean postoperative haemoglobin concentration Measure Assessment of the requirement of postoperative blood transfusion Measure Mean number of blood transfusions Measure Postoperative Quality of Recovery(QoR)-15 questionnaire score Measure Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores Measure Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores Measure Mean Change in Quality of life measured with the SF-36 scores Measure Clinical surgical site infection Measure Clinical surgical complications Measure Postoperative length of hospital stay Measure Rate of hospital readmission
Time Frame Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose Time Frame Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose Time Frame Haemoglobin concentration will be measured at 28 and 60 days after surgery Time Frame Day 0 to 28 days following surgery Time Frame Day 0 to 28 days following surgery Time Frame Post-operation day 1 (24 hours ± 12 hours following surgery) Time Frame Baseline to 0-3 days prior to surgery and at 23-33 days postoperative Time Frame Baseline to 0-3 days prior to surgery and at 23-33 days postoperative Time Frame Baseline to 0-3 days prior to surgery and at 23-33 days postoperative Time Frame within 28 days following surgery Time Frame within 28 days following surgery Time Frame From Surgery date up to 60 days post surgery Time Frame from discharge date to 28 days post surgery
Description To determine the effect of IV iron supplementation provided at least 21 days prior to surgery for gynecologic malignancy on mean preoperative haemoglobin concentration (in g/L)in patients with iron deficiency anemia compared to those patients without preoperative IV iron supplementation. Description The effect of IV iron supplementation provided prior to surgery for gynecologic malignancy on mean haemoglobin concentration (in g/L) at the time of surgery. Description The effect of IV iron supplementation provided prior to surgery for gynecologic malignancy on mean hemoglobin concentration after the completion of surgery which will be assessed by measuring blood hemoglobin levels Description The number of participants requiring blood transfusion after completion of gynecologic surgery. A blood transfusion event is defined as receiving any volume of one unit or more than one unit of packed red cells or whole blood. Description The mean number of blood transfusion (total number of units of packed red blood cells transfused ) after completion of gynecologic surgery Description Quality of life will be evaluated using Quality of Recovery(QoR)-15 questionnaire score at postoperative day 1 compared to baseline (minimum value : 0, maximum value : 150, the higher the score, the better the result) Description The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being (PWG), social/family (SWB), emotional well being (EWB) and Functional Well-Being (FWB) and an additional 20-item anemia questionnaire that measures fatigue associated items and 7 non-fatigue items. The scales are formatted on 1 to 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general health related quality of life (HRQoL), the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various therapeutic areas, including MDS. Description Health-related quality of life will be measured using the EuroQol Five Dimensions (EQ-5D). The EQ-5D-5L is a valid extension of the 3-level questionnaire. It can be defined as a standardized non-disease specific value-based instrument to describe and value health-related quality of life. The instrument consists of two components: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health). The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health. Description The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Minimum Value: 0 (worst outcome) Maximum Value: 100 (best outcome) Description Rate of participants presenting with clinical surgical site infection will be measured post-operation. Description Proportion of participants experiencing any complication post-operatively Description Mean and median length of stay (in days) in hospital following surgery Description Proportion of participants requiring re-admission to hospital following surgery after initial discharge

Browse Conditions

Sequence: 193879906 Sequence: 193879907 Sequence: 193879908 Sequence: 193879909 Sequence: 193879910 Sequence: 193879911 Sequence: 193879912
Mesh Term Anemia Mesh Term Anemia, Iron-Deficiency Mesh Term Iron Deficiencies Mesh Term Hematologic Diseases Mesh Term Iron Metabolism Disorders Mesh Term Metabolic Diseases Mesh Term Anemia, Hypochromic
Downcase Mesh Term anemia Downcase Mesh Term anemia, iron-deficiency Downcase Mesh Term iron deficiencies Downcase Mesh Term hematologic diseases Downcase Mesh Term iron metabolism disorders Downcase Mesh Term metabolic diseases Downcase Mesh Term anemia, hypochromic
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48415511
Agency Class OTHER
Lead Or Collaborator lead
Name AHS Cancer Control Alberta

Central Contacts

Sequence: 12033530 Sequence: 12033531
Contact Type primary Contact Type backup
Name Steven Bisch, MD Name Kelsey Meyer
Phone 403-521-3721
Email Steven.Bisch@ahs.ca Email Kelsey.Meyer@ahs.ca
Role Contact Role Contact

Design Group Interventions

Sequence: 68288076 Sequence: 68288077
Design Group Id 55708158 Design Group Id 55708159
Intervention Id 52586509 Intervention Id 52586510

Eligibilities

Sequence: 30825225
Gender Female
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254119187
Number Of Facilities 1
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 12

Designs

Sequence: 30571158
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Quadruple
Subject Masked True
Caregiver Masked True
Investigator Masked True
Outcomes Assessor Masked True

Intervention Other Names

Sequence: 26720872
Intervention Id 52586509
Name MONOFERRIC

Responsible Parties

Sequence: 28937574
Responsible Party Type Sponsor