Iron Therapy Arm for Anemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Tom Baker Cancer Centre, Calgary, Canada
Anemia+3 More
Ferric derisomaltose - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Anemia
  • Iron-deficiency
  • Gynecologic Cancers

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Anemia

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Baseline to 0-3 days prior to surgery and at 23-33 days postoperative

Day 33
Mean Change in Quality of life measured with the EQ5D5L (European Quality of Life Five Dimension) scores
Mean Change in Quality of life measured with the SF-36 scores
Mean Change in the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Scores
Day 28
Assessment of the requirement of postoperative blood transfusion
Mean number of blood transfusions
Day 60
Postoperative length of hospital stay
Day 60
Mean postoperative haemoglobin concentration
Day 3
Mean preoperative haemoglobin concentration
Haemoglobin concentration will be measured at baseline and at the time of surgery after treatment with Ferric Derisomaltose
Mean haemoglobin concentration at the time of surgery
Day 1
Postoperative Quality of Recovery(QoR)-15 questionnaire score
Day 28
Rate of hospital readmission
Day 28
Clinical surgical complications
Clinical surgical site infection

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Anemia

Trial Design

2 Treatment Groups

Iron Therapy Arm
1 of 2
Placebo Arm
1 of 2
Experimental Treatment
Non-Treatment Group

82 Total Participants · 2 Treatment Groups

Primary Treatment: Iron Therapy Arm · Has Placebo Group · Phase 3

Iron Therapy Arm
Drug
Experimental Group · 1 Intervention: Ferric derisomaltose · Intervention Types: Drug
Placebo Arm
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 0-3 days prior to surgery and at 23-33 days postoperative
Closest Location: Tom Baker Cancer Centre · Calgary, Canada
Photo of tom baker cancer centre  1Photo of tom baker cancer centre  2Photo of tom baker cancer centre  3
2011First Recorded Clinical Trial
4 TrialsResearching Anemia
180 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The indication for the operation may be for suspected or proven gynecologic malignancy.
The study infusion is administered to you for a minimum of 21 days and a maximum of 90 days before the planned operation.
You are expected to be operated on within 28 to 90 days of being recruited.
You have given informed consent prior to study initiation.\n
You have a low haemoglobin level and a low transferrin saturation.
You are of childbearing potential (WOCBP).
WOCBP must adhere to the contraception requirement from screening throughout the study period until 6 weeks post treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.