IV Iron Infusion for Cancer-Related Anemia

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether iron given through an IV (intravenous infusion) can help with anemia (low red blood cell count) in women with current or past ovarian cancer. Anemia can cause fatigue and weakness, affect the effectiveness of cancer treatments, and impact overall quality of life. The study aims to determine if this treatment is safe and effective in addressing these issues. Women with ovarian cancer who have undergone treatment or are currently receiving treatment and experiencing anemia might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for anemia.

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.

Is there any evidence suggesting that IV iron infusion is likely to be safe for humans?

Research has shown that IV iron infusion is generally safe for treating anemia in cancer patients. Studies have found that newer IV iron treatments are effective and safe, with no major side effects. One study found that IV iron increased blood cell production and reduced the need for blood transfusions, without affecting survival rates or causing serious side effects.

Another study examined cancer patients receiving chemotherapy and found that IV iron effectively managed anemia and was well tolerated. Overall, these findings suggest that IV iron is safe and well-tolerated for individuals with cancer-related anemia. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anemia?

Researchers are excited about IV iron infusion for cancer-related anemia because it directly addresses low iron levels, a common underlying cause of anemia, with a faster and more targeted approach compared to oral iron supplements, which are often slow to act and can cause gastrointestinal side effects. Unlike blood transfusions, which are another standard treatment but carry risks like iron overload and infection, IV iron provides a safer alternative by replenishing iron stores without these complications. This treatment could offer a more efficient and comfortable option for patients, potentially improving their quality of life more quickly and effectively.

What evidence suggests that IV iron infusion might be an effective treatment for cancer-related anemia?

Research has shown that administering iron through an IV can help treat anemia in cancer patients. Studies have found that it raises hemoglobin levels, reducing the need for blood transfusions. For instance, one study found that about 50–60% of patients responded well, with fewer needing transfusions. In this trial, participants in the Iron Infusion Arm will receive IV iron treatment. IV iron is usually well tolerated and works for patients with various types of cancer, even those receiving chemotherapy. This suggests that IV iron infusion can be important for improving anemia and possibly enhancing the quality of life for cancer patients. ^{1 3 4 5 6}

Who Is on the Research Team?

Maryam Al-Hayki

Principal Investigator

University of Saskatchewan

Are You a Good Fit for This Trial?

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.

I don't have conditions that prevent IV iron or blood transfusions.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3573441/

The role of intravenous iron in the treatment of anemia ... 2008] has resulted in overall response rates of about 50–60% and the need for blood transfusion has remained high, at about 20–30%. Moreover, during recent ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10529066/

Intravenous Iron Therapy to Treat Anemia in Oncology Overall, the studies reported that the use of IV iron increased hemoglobin concentration and decreased transfusion rates during different cancer treatment ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04187716

Intravenous Iron Injection in Cancer Patients With Anemia This study is a comparative clinical trial of prospective, multicenter, randomized trials to evaluate the efficacy of intravenous iron (Ferinject®) in cancer ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419381232

Prevalence and management of cancer-related anaemia ... Data from several controlled clinical trials have shown that i.v. iron supplementation enhances response to ESA treatment and can reduce administered ESA doses ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.28_suppl.359

Evaluation of clinical use of intravenous iron: Utilization, ... IV iron therapy was well tolerated and effective in treatment of iron-deficiency anemia in patients with gastrointestinal cancer undergoing chemotherapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9317757/

Intravenous Iron Supplementation for the Treatment of ... IV iron has previously been shown to increase the hematopoietic response and to reduce the need for RBC transfusions with no difference in mortality or adverse ...