Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy
Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy
1 other identifier
interventional
64
1 country
1
Brief Summary
Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 14, 2011
CompletedFirst Posted
Study publicly available on registry
September 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedFebruary 1, 2017
January 1, 2017
1.3 years
September 14, 2011
January 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
total number of red blood transfusion units and number of cycles requiring blood transfusion
6 months
Number of participants with adverse events
6 months
Study Arms (2)
Intravenous iron
EXPERIMENTALIron sucrose 200 mg intravenous infusion in 15 minutes
Oral iron
PLACEBO COMPARATORFerrous fumarate 200 mg oral three times a day
Interventions
Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Iron hypersensitivity
- Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia
- Progressive disease
- Bone marrow metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chulalongkorn Hospital
Bangkok, Bangkok, 10330, Thailand
Related Publications (1)
Athibovonsuk P, Manchana T, Sirisabya N. Prevention of blood transfusion with intravenous iron in gynecologic cancer patients receiving platinum-based chemotherapy. Gynecol Oncol. 2013 Dec;131(3):679-82. doi: 10.1016/j.ygyno.2013.09.028. Epub 2013 Oct 5.
PMID: 24099839DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tarinee Manchana, MD
Chulalongkorn University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Obstetrics and Gynecology
Study Record Dates
First Submitted
September 14, 2011
First Posted
September 16, 2011
Study Start
June 1, 2011
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
February 1, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share