Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?

Detailed Description
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Anemia is a common condition during chemotherapy administration. Treatment options usually include oral iron supplementation and blood transfusion. However, oral iron has gastrointestinal side effects, which affects patient compliance, and only a small amount of oral iron can be absorbed from the gastrointestinal tract. Intravenous iron may overcome a block of iron absorption and iron recycling induced by hepcidin. Therefore, it may increase hemoglobin level and reduced blood transfusion in cancer patients receiving chemotherapy.

Official Title
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Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Drug: Intravenous iron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-70 years Good performance status (Zubrod score < 2) No serious underlying disease Normal renal function test Normal liver function test Platinum based chemotherapy is the first line regimen No prior or receiving radiotherapy Exclusion Criteria: Iron hypersensitivity Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia Progressive disease Bone marrow metastasis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous iron<br>Iron sucrose 200 mg intravenous infusion in 15 minutes | Drug: Intravenous iron<br>* Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy<br>* Other names: Venofer;|
| Placebo Comparator: Oral iron<br>Ferrous fumarate 200 mg oral three times a day | Drug: Intravenous iron<br>* Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy<br>* Other names: Venofer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cell (RBC) transfusion rate | The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total number of red blood transfusion units and number of cycles requiring blood transfusion |  | 6 months | 
| Number of participants with adverse events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous iron, gynecologic cancer blood transfusion