ClinicalTrials.Veeva

Menu

Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

C

Chulalongkorn University

Status and phase

Completed
Phase 3

Conditions

Gynecologic Cancer

Treatments

Drug: Intravenous iron

Study type

Interventional

Funder types

Other

Identifiers

NCT01435200
IV iron 2

Details and patient eligibility

About

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

Full 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.

Enrollment

64 patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups, including a placebo group

Intravenous iron
Experimental group
Description:
Iron sucrose 200 mg intravenous infusion in 15 minutes
Treatment:
Drug: Intravenous iron
Oral iron
Placebo Comparator group
Description:
Ferrous fumarate 200 mg oral three times a day
Treatment:
Drug: Intravenous iron

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems