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Iron Supplement
IV Iron Infusion for Cancer-Related Anemia
Phase 3
Waitlist Available
Led By Maryam Al-Hayki
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients on any active cancer treatment or with history of previous chemotherapy, surgery, radiation, PARP, biologics, and hormonal treatment
Perioperative patients having upfront surgery or at interval or secondary debulking surgery
Must not have
Palliative patients with life expectancy 6 months or less
Medical conditions with contraindication to IV iron infusion or blood transfusion (Example: iron overload, hemosiderosis, decompensated liver cirrhosis, or active hepatitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up hgb will be checked just prior to treatment and then biweekly until week 8 or whenever hgb rises at least by 20 g/l through the treatment period, upto 3 years.
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial aims to investigate the use of intravenous (IV) iron infusion in managing anemia in patients with ovarian cancer. Anemia is a common issue in cancer patients and can impact their treatment outcomes
Who is the study for?
This trial is for ovarian cancer patients who are experiencing anemia, either as a new symptom or during their cancer treatment. It's important that participants have not had any iron treatments recently and do not have other medical conditions that could affect the study results.
What is being tested?
The trial is testing whether giving iron directly into the bloodstream can help with anemia in people with ovarian cancer. The goal is to see if this improves how long they live, their energy levels, and overall well-being.
What are the potential side effects?
Possible side effects of IV iron infusion include allergic reactions, infections at the injection site, changes in blood pressure, headaches, dizziness, nausea or vomiting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had cancer treatments like chemotherapy, surgery, or hormone therapy.
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I am scheduled for or have had surgery to remove a tumor.
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I am a woman aged 18 or older.
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I am fit for cancer treatment and expected to live more than 6 months.
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I have had 2 or fewer chemotherapy treatments.
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My ovarian cancer is confirmed and is stage IC-IV.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My doctor expects I have 6 months or less to live.
Select...
I don't have conditions that prevent IV iron or blood transfusions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ hgb will be checked just prior to treatment and then biweekly until week 8 or whenever hgb rises at least by 20 g/l through the treatment period, upto 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~hgb will be checked just prior to treatment and then biweekly until week 8 or whenever hgb rises at least by 20 g/l through the treatment period, upto 3 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in QOL (quality of Life)
Delay In Chemotherapy
Efficiency of IV iron
+3 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Iron Infusion ArmExperimental Treatment1 Intervention
Group A: Treatment study group All patients will be treated with iron infusion for Hgb lower than 100 g/L and/or TSAT \< 20%.
Group II: No Iron InfusionActive Control1 Intervention
Group B: No iron Infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IV iron
2015
Completed Phase 3
~80
Find a Location
Who is running the clinical trial?
University of SaskatchewanLead Sponsor
256 Previous Clinical Trials
155,177 Total Patients Enrolled
Maryam Al-HaykiPrincipal InvestigatorUniversity of Saskatchewan