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Blood transfusion reduction with intravenous iron in gynaecological cancer patients receiving chemotherapy

Blood transfusion reduction with intravenous iron in gynaecological cancer patients receiving chemotherapy: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN01957333
Enrollment
44
Registered
2009-10-01
Start date
2008-08-31
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Chemotherapy-induced anaemia Cancer Malignant neoplasms of female genital organs

Interventions

Study group: Iron sucrose 200 mg intravenous drip over 30 minutes as a single dose Control group: Ferrous sulphate 200 mg oral three times a day until the next cycle of chemotherapy Patients will be

Sponsors

Chulalongkorn University (Thailand)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female participants aged 20 - 65 years 2. Normal liver function 3. Normal kidney function 4. No prior radiotherapy or having received radiotherapy 5. At least one remaining cycle of chemotherapy

Exclusion criteria

Exclusion criteria: 1. Iron hypersensitivity 2. Risk of iron overload such as chronic renal failure or thalassaemia major 3. Progressive disease 4. Bone marrow metastasis 5. Inability to monitor weekly complete blood counts

Design outcomes

Primary

MeasureTime frame
The incidence of blood transfusion at the consecutive cycle of chemotherapy between oral and intravenous iron, measured at the time of next cycle of chemotherapy (3 - 4 weeks depending on the chemotherapy regimen).

Secondary

MeasureTime frame
In both groups, assessed at the next cycle of chemotherapy (3 - 4 weeks depended on the chemotherapy regimen): 1. Haemoglobin and haematocrit increment 2. Number of blood transfusion units 3. Adverse events 4. Quality of life (QOL), also measured before treatment

Countries

Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026