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


Phase 3
20 Years
70 Years
Open (Enrolling)
Female
Gynecologic Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Red blood cell (RBC) transfusion rate

Outcome Description:

The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Tarinee Manchana, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chulalongkorn University

Authority:

Thailand: Ethical Committee

Study ID:

IV iron 2

NCT ID:

NCT01435200

Start Date:

June 2011

Completion Date:

November 2012

Related Keywords:

  • Gynecologic Cancer
  • Intravenous iron
  • gynecologic cancer blood transfusion

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