A randomised controlled trial to assess the efficacy and safety of patient controlled maligant pleural effusion drainage by indwelling ambulatory pleural catheter, compared to standard care
| ISRCTN | ISRCTN87514420 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87514420 |
| EudraCT/CTIS number | 2006-006630-18 |
| Secondary identifying numbers | TIME 2 |
- Submission date
- 07/03/2007
- Registration date
- 30/04/2007
- Last edited
- 19/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=48
Contact information
Mrs Emma Hedley
Scientific
Scientific
Respiratory Trials Unit
Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
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 | |
| Study acronym | The second therapeutic intervention in malignant effusion trial (TIME2) |
| Study objectives | A cancer induced collection of fluid between the lung and the chest wall (a pleural effusion) affects about 250,000 new patients each year (UK&US), including 25% of patients with lung cancer, 95% with mesothelioma and 40% with breast cancer. The accumulated fluid compresses the lung causing disabling breathlessness that requires painful pleural procedures to drain the fluid. Standard care includes adhering the lung to the chest wall (pleurodesis) which is painful and must be repeated in about 20% of patients. This is then followed by repeated fluid drainage if it fails. These procedures carry significant costs. The advent of tunnelled ambulatory small-bore chest catheters, drained as required by patients and their carers, presents a different and potentially better strategy. Treatment could be almost entirely outpatient, with the patient controlling their drainage and free from the pain and costs of pleurodesis/drainage; though with the disadvantage of the indwelling catheter. Patients able to promptly drain their own catheter as needed should produce better breathlessness control than intermittent hospital treatment (the primary aim of pleurodesis). This study is a randomised trial which will compare how well breathlessness is controlled by an indwelling catheter compared to standard care in 114 patients with cancer induced pleural effusion and will measure the frequency of problems with the two treatment strategies. If this trial is positive, it will directly improve care for one of the commonest respiratory problems, to the benefit of >250,000 patients each year. |
| Ethics approval(s) | Milton Keynes Local Research Ethics Committee (ref: 07/Q1603/2) |
| Health condition(s) or problem(s) studied | Pleural effusion |
| Intervention | Patients will be randomly assigned (1:1) to either an indwelling ambulatory pleural catheter or standard care for their malignant pleural effusion. Computer derived allocation will be delivered by the established Oxford/London MRC Clinical Trials Unit systems. In order to minimise biases in trial results randomisation will include minimisation for histological tissue type (mesothelioma vs. non-mesothelioma) as survival is increased in mesothelioma, and the risk of catheter associated subcutaneous tumour invasion may be higher with mesothelioma, and for WHO performance status (0/1 vs. 2/3). |
| Intervention type | Other |
| Primary outcome measure | The primary outcome will be the average daily Visual Analogue Scale (VAS) defining breathlessness, after removing "breathlessness unresponsive to pleural fluid drainage" - defined as the VAS following first complete pleural fluid drainage. Patients will also record how much their breathlessness has bothered them each day. The daily VAS will be performed at a similar time each day. The patients will perform VAS and record breathlessness for 6 weeks. |
| Secondary outcome measures | The following will be assessed at time of the primary outcome measure and recorded throughout the year of the trial: 1. Average daily chest pain assessed using VAS score for 6 weeks 2. Self reported health status (quality of life) assessed using Chronic Respiratory Disease Questionnaire (CRDQ) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) 3. Economic assessment: direct quantification of clinical costs from patient kept diary records and estimated health care costs (Euroqol-5 Dimensions [EQ-5D] Questionnaire) 4. Spontaneous pleurodesis rate with ambulatory catheters (This will differ for each patient and will be recorded individually) 5. Complication rate with ambulatory catheters (Any complications that arise will be documented throughout the duration of the study) |
| Overall study start date | 01/04/2006 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 114 |
| Key inclusion criteria | 1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by: a. Histocytologically proven pleural malignancy or b. Recurrent large pleural effusion in the context of histologically proven cancer outside the thorax. 2. Written informed consent |
| Key exclusion criteria | 1. Age < 18 years 2. Beginning chemotherapy in the next 4 weeks 3. Expected survival <3 months 4. Chylothorax 5. Previous lobectomy or pneumonectomy on the side of the effusion 6. Previous attempted pleurodesis 7. Pleural infection 8. Total blood white cell count <1.0 x 109 9. Hypercapnic ventilatory failure 10. Patients who are pregnant or lactating 11. Irreversible bleeding diathesis 12. Irreversible visual impairment 13. Inability to give informed consent or comply with the protocol |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Respiratory Trials Unit
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
Clinical Trials and Research Governance
Manor House
The John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Charity
British Lung Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BLF
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/06/2012 | Yes | No | |
| Results article | results | 01/10/2014 | Yes | No |
