Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

This study has been completed.
Information provided by (Responsible Party):
Tarinee Manchana, Chulalongkorn University Identifier:
First received: September 14, 2011
Last updated: July 22, 2013
Last verified: July 2013
Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?

Condition Intervention Phase
Gynecologic Cancer
Drug: Intravenous iron
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • total number of red blood transfusion units and number of cycles requiring blood transfusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: June 2011
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01435200

Chulalongkorn Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Principal Investigator: Tarinee Manchana, MD Chulalongkorn University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tarinee Manchana, Department of Obstetrics and Gynecology, Chulalongkorn University Identifier: NCT01435200     History of Changes
Other Study ID Numbers: IV iron 2 
Study First Received: September 14, 2011
Last Updated: July 22, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
Intravenous iron
gynecologic cancer blood transfusion

Additional relevant MeSH terms:
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements processed this record on April 27, 2016