Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

Phase 3

Completed

• Conditions: Gynecologic Cancer
• Interventions: Drug: Intravenous iron

• Registration Number: NCT01435200
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous iron	Intravenous iron	Iron sucrose 200 mg intravenous infusion in 15 minutes
Oral iron	Intravenous iron	Ferrous fumarate 200 mg oral three times a day

Primary Outcome Measures

Name	Time	Method
Red blood cell (RBC) transfusion rate	6 months	The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.

Secondary Outcome Measures

Name	Time	Method
total number of red blood transfusion units and number of cycles requiring blood transfusion	6 months
Number of participants with adverse events	6 months

Trial Locations

Locations (1)

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand