Blood transfusion reduction with intravenous iron in gynaecological cancer patients receiving chemotherapy
| ISRCTN | ISRCTN01957333 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01957333 |
| Secondary identifying numbers | N/A |
- 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
Scientific
1873 Rama IV, Patumwan
Bangkok
10330
Thailand
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Intravenous iron |
| Primary outcome measure | 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 study start date | 31/08/2008 |
| Completion date | 31/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 44 patients |
| 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
10330
Thailand
Sponsor information
Chulalongkorn University (Thailand)
University/education
University/education
Faculty of Medicine
Department of Obstetrics and Gynaecology
1873, Rama IV, Patumwan
Bangkok
10330
Thailand
| Website | http://chula.ac.th/chula/th/index_king60.html |
|---|---|
"ROR" |
https://ror.org/028wp3y58 |
Funders
Funder type
University/education
Chulalongkorn University (Thailand) - Department of Obstetrics and Gynaecology, Faculty of Medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
