Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435200
• Other study ID #: IV iron 2
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2011
• Last updated: January 31, 2017
• Start date: June 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2017
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Drug:
• Intravenous iron
Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy

Locations

Country	Name	City	State
Thailand	Chulalongkorn Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	total number of red blood transfusion units and number of cycles requiring blood transfusion		6 months
Secondary	Number of participants with adverse events		6 months