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

Primary Purpose

Gynecologic Cancer, Anemia, Iron-deficiency

Status

Not yet recruiting

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Ferric derisomaltose

Placebo

About this trial

This is an interventional treatment trial for Gynecologic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:
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.
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.

Sites / Locations

Tom Baker Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Iron Therapy Arm

Placebo Arm

Arm Description

500 or 1000mg of IV Ferric Derisomaltose in 100mL normal saline will be administered intravenously over 1 hour. Participants with bodyweight <50kg will receive 500mg, participants with bodyweight >50kg will receive 1000mg to ensure no patient exceeds the manufacturer's recommended dose of 20mg/kg bodyweight.

100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.

Outcomes

Primary Outcome Measures

Mean preoperative haemoglobin concentration

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.

Secondary Outcome Measures

Mean haemoglobin concentration at the time of surgery

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.

Mean postoperative haemoglobin concentration

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

Assessment of the requirement of postoperative blood transfusion

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.

Mean number of blood transfusions

The mean number of blood transfusion (total number of units of packed red blood cells transfused ) after completion of gynecologic surgery

Postoperative Quality of Recovery(QoR)-15 questionnaire score

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)

Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores

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.

Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores

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.

Mean Change in Quality of life measured with the SF-36 scores

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)

Clinical surgical site infection

Rate of participants presenting with clinical surgical site infection will be measured post-operation.

Clinical surgical complications

Proportion of participants experiencing any complication post-operatively

Postoperative length of hospital stay

Mean and median length of stay (in days) in hospital following surgery

Rate of hospital readmission

Proportion of participants requiring re-admission to hospital following surgery after initial discharge

Full Information

NCT ID

NCT05407987

First Posted

June 1, 2022

Last Updated

September 15, 2023

Sponsor

AHS Cancer Control Alberta

1. Study Identification

Unique Protocol Identification Number

NCT05407987

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 1, 2024 (Anticipated)

Primary Completion Date

September 30, 2025 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AHS Cancer Control Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gynecologic Cancer, Anemia, Iron-deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iron Therapy Arm

Arm Type

Experimental

Arm Description

Arm Title

Placebo Arm

Arm Type

Placebo Comparator

Arm Description

100mL of normal saline will be administered intravenously over 1 hour between 21 and 90 days preceding surgical intervention.

Intervention Type

Drug

Intervention Name(s)

Ferric derisomaltose

Other Intervention Name(s)

MONOFERRIC

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Mean preoperative haemoglobin concentration

Description

Time Frame

Haemoglobin concentration will be measured at baseline and 3 days prior to surgery after treatment with Ferric Derisomaltose

Secondary Outcome Measure Information:

Title

Mean haemoglobin concentration at the time of surgery

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.

Time Frame

Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose

Title

Mean postoperative haemoglobin concentration

Description

Time Frame

Haemoglobin concentration will be measured at 28 and 60 days after surgery

Title

Assessment of the requirement of postoperative blood transfusion

Description

Time Frame

Day 0 to 28 days following surgery

Title

Mean number of blood transfusions

Description

The mean number of blood transfusion (total number of units of packed red blood cells transfused ) after completion of gynecologic surgery

Time Frame

Day 0 to 28 days following surgery

Title

Postoperative Quality of Recovery(QoR)-15 questionnaire score

Description

Time Frame

Post-operation day 1 (24 hours ± 12 hours following surgery)

Title

Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores

Description

Time Frame

Baseline to 0-3 days prior to surgery and at 23-33 days postoperative

Title

Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores

Description

Time Frame

Baseline to 0-3 days prior to surgery and at 23-33 days postoperative

Title

Mean Change in Quality of life measured with the SF-36 scores

Description

Time Frame

Baseline to 0-3 days prior to surgery and at 23-33 days postoperative

Title

Clinical surgical site infection

Description

Rate of participants presenting with clinical surgical site infection will be measured post-operation.

Time Frame

within 28 days following surgery

Title

Clinical surgical complications

Description

Proportion of participants experiencing any complication post-operatively

Time Frame

within 28 days following surgery

Title

Postoperative length of hospital stay

Description

Mean and median length of stay (in days) in hospital following surgery

Time Frame

From Surgery date up to 60 days post surgery

Title

Rate of hospital readmission

Description

Proportion of participants requiring re-admission to hospital following surgery after initial discharge

Time Frame

from discharge date to 28 days post surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steven Bisch, MD

Phone

403-521-3721

Steven.Bisch@ahs.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Kelsey Meyer

Kelsey.Meyer@ahs.ca

Facility Information:

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Bisch, MD

Phone

403-521-3721

Steven.Bisch@ahs.ca

First Name & Middle Initial & Last Name & Degree

Kelsey Meyer

Kelsey.Meyer@ahs.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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