Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

January 31, 2017 updated by: Tarinee Manchana, Chulalongkorn University

Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Venofer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 6 months
6 months
total number of red blood transfusion units and number of cycles requiring blood transfusion
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Tarinee Manchana, MD, Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 16, 2011

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IV iron 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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