Condition category
Cancer
Date applied
25/01/2013
Date assigned
06/03/2013
Last edited
06/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Jonathan Moss

ORCID ID

Contact details

Dept of Radiology
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 0DY
United Kingdom
jon.moss@ggc.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol/Serial No: MI93

Study information

Scientific title

Port-a-cath and Hickman line devices for chemotherapy delivery: A randomised phase II study and pre-trial economic model development to inform the design of a subsequent randomised phase III controlled trial

Acronym

Study hypothesis

The study hypothesis is that Ports are cost effective for the delivery of chemotherapy and that it is not appropriate to deny these devices to patients on grounds of purchasing costs alone. Although Ports are a little more difficult to insert and more expensive than Hickman lines, they carry potential advantages such as reduced infection and re-intervention rates, reduced maintenance and superior patient acceptability.

Ethics approval

West of Scotland REC 1, 5th April 2011, ethics reference number: 11/AL/0083

Study design

Multi-centre open randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please contact Judith Dixon [judith.dixon@glasgow.ac.uk] to request a patient information sheet

Condition

Cancer, Chemotherapy, device study

Intervention

Patients will be randomised in a 3:1 ratio to receive either a Hickman line (n=75) or a Port-a-cath (n=25).

Patients participating in the study will be asked to complete quality of life questionnaires (EQ-5D and device-specific) at baseline and subsequently monthly (sent out to the patients at home) during the insertion period; a further questionnaire will be completed at the time of planned line removal.

Patients will be seen as per standard of care for their treatment. Complication forms will be completed on a monthly basis by CTU Glasgow staff.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

Cost effectiveness of Ports

Secondary outcome measures

Complication data including line infection (with and without antibiotics), tract infection, (with/without antibiotics), occlusion, migration, loss of line, central vein thrombosis, exit site haematoma, and skin breakdown will be recorded by clinical staff, on complication forms in case notes, as events occur and data collected by the clinical trial coordinator. Reinterventions including line replacement, thrombolysis, stripping and manipulations will be recorded by clinical staff, on complication forms in case notes, as events occur and data collected by the clinical trial coordinator.

Overall trial start date

01/08/2011

Overall trial end date

31/07/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Oncology patients with solid tumours who are scheduled for access line insertion
2. Patients must be willing and clinically able to receive either a Hickman line or a Port-a-cath
3. Patient must provide informed consent
4. Age ≥18 years, male and female
5. Able to comply with study protocol

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Any evidence of any medical or psychiatric disorders that would be a contra indication to study participation
2. Life expectancy < 3 months

Recruitment start date

01/08/2011

Recruitment end date

31/07/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Radiology
Glasgow
G12 0DY
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

c/o Dr Nathaniel Brittain
Academic Research Co-ordinator
Research and Development
Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom
Nathaniel.Brittain@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nhsggc.org.uk

Funders

Funder type

Government

Funder name

Chief Scientist Office (UK) - Scottish Government (CZG/2/512)

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