Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy
Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy|
- Red blood cell (RBC) transfusion rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.
- Hemoglobin and hematocrit level [ Time Frame: 6 months ] [ Designated as safety issue: No ]The level of hemoglobin and hematocrit before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.
- Number of participants with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: Intravenous iron
Iron sucrose 200 mg intravenous infusion in 15 minutes
Drug: Intravenous iron
Intravenous iron 200 mg add in 0.9% NSS 100 ml infused within 15 minutes after every cycles of chemotherapy
Other Name: Venofer
Placebo Comparator: Oral iron
Ferrous fumarate 200 mg oral three times a day
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.
|Contact: Punnada Athibovonsuk, MDemail@example.com|
|Bangkok, Thailand, 10330|
|Contact: Punnada Athibovonsuk, MD firstname.lastname@example.org|
|Principal Investigator:||Tarinee Manchana, MD||Chulalongkorn University|