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Completed

NCT Number: NCT01435200

Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

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

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Key information

Conditions

Gynecologic Cancer

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Chulalongkorn Hospital

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous iron

Drug

Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy

Other names: Venofer

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2011
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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