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Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

This study is currently recruiting participants.
Verified July 2012 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Tarinee Manchana, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01435200
First received: September 14, 2011
Last updated: July 28, 2012
Last verified: July 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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:
  • 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 ]

Estimated Enrollment: 60
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)
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435200

Contacts
Contact: Punnada Athibovonsuk, MD yo_ay25@hotmail.com

Locations
Thailand
Chulalongkorn Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Punnada Athibovonsuk, MD         yo_ay25@hotmail.com    
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Tarinee Manchana, MD Chulalongkorn University
  More Information

No publications provided

Responsible Party: Tarinee Manchana, Department of Obstetrics and Gynecology, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01435200     History of Changes
Other Study ID Numbers: IV iron 2
Study First Received: September 14, 2011
Last Updated: July 28, 2012
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Iron
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013