Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Contact information



Primary contact

Prof Jon Moss


Contact details

Professor Jon Moss
Interventional Radiology Unit
Gartnavel General Hospital
1053 Great Western Road
G12 0YN
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

CAVA 2013

Study information

Scientific title

Cancer And Venous Access (CAVA) – A randomised controlled trial with associated qualitative research of venous access devices for the delivery of long-term chemotherapy



Study hypothesis

To determine which venous access device - subcutaneously tunnelled central catheters (Hickman type device), peripherally inserted central catheters (PICC) or implantable chest wall ports (Port) - offers the best outcome from safety, clinical effectiveness and cost effectiveness perspectives.

More details can be found at

Ethics approval

Ethics approval has been sought from the West of Scotland REC 1. Reference Number: 13/WS/0056. Provisional approval for the CAVA trial was received on 11/03/2013.

Study design

Randomised controlled trial incorporating pre and post trial qualitative research

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Venous Access in Cancer Patients


All patients will receive either a Port, PICC or Hickman Type device. There are four possible randomisation options for each patient. The site or patient will chose which randomisation option to be part of and then the patient will be randomised between the possible devices in that option. The options are:
• Hickman type device versus PICC
• Hickman type device versus chest wall port
• PICC versus chest wall port
• Hickman type device versus PICC versus chest wall port

Intervention type



Not Applicable

Drug names

Primary outcome measure

The primary outcome for the randomised trial is complication rate, a composite of infection (suspected or confirmed) and/or mechanical failure. This will be analysed using logistic regression including terms for treatment group and randomisation stratification factors.

Secondary outcome measures

An analysis will also be conducted based on complication event rate data 13. This analysis will estimate the effect of the access devices on the individual component complications (infections and mechanical failure) and will allow an assessment of the similarity of these effects via a likelihood ratio test. The incidence of venous thrombosis will be compared using logistic regression and also as an event rate. The frequency of the various complications will be assessed. The total duration of treatment interruptions will be summarised and compared using a Mann Whitney U-test.

Scores for the five dimensions of the EQ-5D (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the visual analogue score for health will be summarised and the EQ-5D curves will be compared between treatment groups using an area under curve (AUC) approach standardised for the period on study and using the baseline value as a covariate.

Scores for the 5 functional scales (physical, role, emotional, cognitive, social) and 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties) of the EORTC QLQ-C30 will be calculated according to standard EORTC conventions, as will global health status score. These scores will be summarised and analysed as EQ-5D.

The results from the device-specific questionnaire will be summarised only.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Aged ≥ 18 years
2. Receiving or to receive chemotherapy
3.Duration of chemotherapy ≥ 12 weeks
4. Clinical team uncertain as to which device is optimal for this indication
5. Solid or haematological malignancy
6. Suitable upper extremity vein for all the access devices to which the patient may be randomised
7. Able to provide written informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Life or treatment expectancy <3 months
2.Previous venous access device removed due to complication within last three months
3. Requirement for high volume (apheresis) line
4. Need for catheter to be placed in a non upper extremity vein
5. Patient previously randomised into the CAVA tria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Gartnavel General Hospital
G12 0YN
United Kingdom

Sponsor information


NHS Greater Glasgow and Clyde (UK)

Sponsor details

Dr Nathaniel Brittain
Academic Research Co-ordinator
NHS Greater Glasgow and Clyde
Research and Development Central Office
The Tennent Institute
1st Floor
Western Infirmary General
38 Church Street
G11 6NT
United Kingdom

Sponsor type




Funder type


Funder name

NIHR Health Technology Assessment (HTA) programme (project reference 11/67/01).

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2020 patient acceptability qualitative results in (added 04/08/2020)

Publication citations

Additional files

Editorial Notes

04/08/2020: Publication reference added. 04/12/2019: The following changes were made to the trial record: 1. The recruitment end date was updated from 28/02/2018 to 28/02/2019. 2. The overall trial end date was updated from 28/02/2019 to 30/09/2019. 3. The intention to publish date was updated from 30/09/2019 to 01/02/2020. 19/10/2018: The following changes were made to the trial record: 1. The recruitment end date was updated from 30/09/2018 to 28/02/2018. 2. The overall trial end date was updated from 30/09/2018 to 28/02/2019. 3. The intention to publish date was added.