Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Blood transfusion reduction with intravenous iron in gynaecological cancer patients receiving chemotherapy: a randomised controlled trial
Acronym
Study hypothesis
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
Ethics Committee of Chulalongkorn University approved on the 28th August 2008 (ref: 237/51)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Intravenous iron
Primary outcome measures
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 outcome measures
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
Overall trial start date
31/08/2008
Overall trial end date
31/07/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
44 patients
Participant 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
Recruitment start date
31/08/2008
Recruitment end date
31/07/2009
Locations
Countries of recruitment
Thailand
Trial participating centre
1873 Rama IV, Patumwan
Bangkok
10330
Thailand
Sponsor information
Organisation
Chulalongkorn University (Thailand)
Sponsor details
Faculty of Medicine
Department of Obstetrics and Gynaecology
1873
Rama IV
Patumwan
Bangkok
10330
Thailand
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Chulalongkorn University (Thailand) - Department of Obstetrics and Gynaecology, Faculty of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary