Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01435200

Enrollment

Registered

2011-09-16

Start date

2011-06-30

Completion date

2012-11-30

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Cancer

Keywords

Intravenous iron, gynecologic cancer blood transfusion

Brief summary

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

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.

Interventions

DRUGIntravenous iron

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Red blood cell (RBC) transfusion rate	6 months	The requirement of red blood cell transfusion before administration of chemotherapy will be evaluated for 6 cycles of chemotherapy.

Secondary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026