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

ISRCTN	ISRCTN01957333
DOI	https://doi.org/10.1186/ISRCTN01957333
Protocol serial number	N/A
Sponsor	Chulalongkorn University (Thailand)
Funder	Chulalongkorn University (Thailand) - Department of Obstetrics and Gynaecology, Faculty of Medicine

Submission date: 22/09/2009
Registration date: 01/10/2009
Last edited: 12/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tarinee Manchana
Scientific

1873 Rama IV, Patumwan
Bangkok
10330
Thailand

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Blood transfusion reduction with intravenous iron in gynaecological cancer patients receiving chemotherapy: a randomised controlled trial
Study objectives	Chemotherapy-induced anaemia is common in gynaecological cancer patients. Blood transfusion is the main treatment for this, however it has some serious adverse events. Most of the patients who have had a blood transfusion for chemotherapy-induced anaemia continue to require transfusions in the consecutive cycles. This randomised controlled trial is aimed at exploring whether intravenous iron could reduce the need for blood transfusions in anaemic gynaecological cancer patients receiving platinum-based chemotherapy.
Ethics approval(s)	Ethics Committee of Chulalongkorn University approved on the 28th August 2008 (ref: 237/51)
Health condition(s) or problem(s) studied	Chemotherapy-induced anaemia
Intervention	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 contacted every week for monitoring of their complete blood count until the next cycle of chemotherapy (3 - 4 weeks depending on the chemotherapy regimen).
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Intravenous iron
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	31/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	44
Key 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
Key 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
Date of first enrolment	31/08/2008
Date of final enrolment	31/07/2009

Locations

Countries of recruitment

Thailand

Study participating centre

1873 Rama IV, Patumwan

Bangkok
10330
Thailand

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes