IV Iron Infusion for Cancer-Related Anemia

Recruiting at1 trial location

Overseen by Maryam Al-Hayki

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Saskatchewan

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Cancer related anemia (CRA) is a common sign occurring in more than 30% of patients at diagnosis, prior to initiation of antineoplastic therapy. Anemia is known to impact survival, disease progression, treatment efficacy, and the patient's quality of life. Proinflammatory cytokines, mainly IL-6, which are released by both tumor and immune cells, play a pivotal action in CRA etiopathogenesis: they promote alterations in erythroid progenitor proliferation, erythropoietin (EPO) production, survival of circulating erythrocytes, iron balance, redox status, and energy metabolism, all of which can lead to anemia. Chronic inflammatory conditions such as cancer influences a compromised nutritional status, which in-turn may contribute to anemia. This study aims to study the role of intravenous (IV) iron infusion in the management of anemia presented in patients previously treated or currently being treated for ovarian cancer. The study aims to identify the safety and efficacy of IV iron infusion on anemia in ovarian cancer patients, and the effect on quality of life and overall survival

Research Team

Maryam Al-Hayki

Principal Investigator

University of Saskatchewan

Eligibility Criteria

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.

Inclusion Criteria

I am able to understand and sign the consent form.

I have had cancer treatments like chemotherapy, surgery, or hormone therapy.

I am currently receiving treatment for cancer before or after surgery, or for advanced cancer.

Exclusion Criteria

Patients who would not consent for IV iron infusion or blood transfusion (Example: Jehovah's Witness)

My doctor expects I have 6 months or less to live.

History of known severe hypersensitivity to IV iron transfusion with the study iron products

Treatment Details

Interventions

• IV Iron (Iron Supplement)

Trial Overview 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.

Participant Groups

Group I: Iron Infusion Arm Experimental Treatment 1 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 Infusion Active Control 1 Intervention

Group B: No iron Infusion

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Scott Livingstone

University of Saskatchewan

Chief Executive Officer since 2024

Bachelor of Science in Pharmacy and Master of Science in Clinical Pharmacy from the University of Saskatchewan

Dr. Angela Bedard-Haughn

University of Saskatchewan

Chief Medical Officer

MD from McGill University