IV Iron Infusion for Cancer-Related Anemia

Recruiting at 1 trial location

Overseen By Rashmi Nagaraj

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: University of Saskatchewan

Disqualifiers: Iron overload, Liver cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

200 Participants Needed

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

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment IV Iron Infusion for Cancer-Related Anemia?

Research shows that IV iron can significantly increase hemoglobin levels in anemic cancer patients, which may improve their quality of life and reduce the need for blood transfusions. Studies also indicate that IV iron is effective in decreasing the percentage of patients requiring blood transfusions and increasing the body's response to produce more red blood cells. ^{1 2 3 4 5}

Is IV iron infusion safe for humans, including those with cancer-related anemia?

IV iron infusions are generally considered safe for humans, including those with cancer-related anemia. Studies show that while there are some adverse events like urticaria (hives) and chest pain, serious reactions are rare. Newer IV iron formulations are safe and effective, with no significant difference in adverse events compared to oral iron. ^{3 4 6 7 8}

How does the drug IV Iron differ from other treatments for cancer-related anemia?

IV Iron is unique because it is administered directly into the bloodstream, which can lead to a faster increase in hemoglobin levels compared to oral iron, and it reduces the need for blood transfusions without increasing adverse events. This makes it particularly beneficial for patients with poor absorption of oral iron or those who need a rapid response. ^{1 2 3 5 9}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive IV iron infusion or no iron infusion, with frequent monitoring of hemoglobin levels

8 weeks

Biweekly visits for Hgb monitoring

Follow-up

Participants are monitored for safety, efficacy, and quality of life changes post-treatment

Up to 3 years

Every 3 months

Open-label extension (optional)

Participants may continue to receive IV iron infusion as needed based on hemoglobin levels and physician discretion

Long-term

Treatment Details

Interventions

• IV Iron

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+

Findings from Research

In a study of 396 patients with chemotherapy-induced anemia, the combination of darbepoetin alpha and intravenous (IV) iron resulted in a significantly higher hematopoietic response rate (86% vs. 73%) compared to standard practice, which included oral iron or no iron.

The addition of IV iron also led to fewer red blood cell transfusions (9% vs. 20%) during treatment, indicating improved efficacy without compromising safety, as both treatment regimens were well tolerated with similar adverse event profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. Bastit, L., Vandebroek, A., Altintas, S., et al.[2015]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Intravenous iron therapy for anemic cancer patients: a review of recently published clinical studies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Is there any role of intravenous iron for the treatment of anemia in cancer? [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Intravenous Iron Supplementation for the Treatment of Chemotherapy-Induced Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Intravenous Iron Therapy to Treat Anemia in Oncology: A Mapping Review of Randomized Controlled Trials. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Role of Intravenous Iron in the Treatment of Anemia Associated with Cancer and Chemotherapy. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Intravenous iron: do we adequately understand the short- and long-term risks in clinical practice? [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative rates of adverse events with different formulations of intravenous iron. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized, multicenter, controlled trial comparing the efficacy and safety of darbepoetin alpha administered every 3 weeks with or without intravenous iron in patients with chemotherapy-induced anemia. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

The role of intravenous iron in cancer-related anemia. [2016]