Condition category
Cancer
Date applied
22/09/2009
Date assigned
01/10/2009
Last edited
12/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Tarinee Manchana

ORCID ID

Contact details

1873 Rama IV
Patumwan
Bangkok
10330
Thailand

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

http://chula.ac.th/chula/th/index_king60.html

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

Publication citations

Additional files

Editorial Notes