ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01435200
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Tarinee Manchana, Chulalongkorn University

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

Condition or disease Intervention/treatment Phase
Gynecologic Cancer Drug: Intravenous iron Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy
Study Start Date : June 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intravenous iron
Iron sucrose 200 mg intravenous infusion in 15 minutes
Drug: Intravenous iron
Intravenous iron 200 mg add in 0.9% Normal saline 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
Drug: Intravenous iron
Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy
Other Name: Venofer



Primary Outcome Measures :
  1. Red blood cell (RBC) transfusion rate [ Time Frame: 6 months ]
    The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.


Secondary Outcome Measures :
  1. total number of red blood transfusion units and number of cycles requiring blood transfusion [ Time Frame: 6 months ]
  2. Number of participants with adverse events [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435200


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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