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ISRCTN
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ISRCTN33288337
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ClinicalTrials.gov identifier
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NCT00644319
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Public title
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The first Therapeutic Interventions in Malignant Effusion trial
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Scientific title
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Acronym
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TIME 1
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Serial number at source
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1.1
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Study hypothesis
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The TIME1 study is a 2 x 2 randomised factorial trial to assess whether non-steroidal (ibuprofen) analgesia and the use of small bore chest tubes will reduce pain during pleurodesis for malignant effusion, compared to standard care. The trial will also define whether non-steroidal use decreases pleurodesis efficacy.
Please note that as of 01/05/2008 the anticipated start and end dates of this trial have been updated. The previous dates were as follows:
Previous anticipated start date: 01/09/2006
Previous anticipated end date: 01/09/2008
As of 22/02/2011 the anticipated end date for this trial has again been extended.
Previous anticipated end date: 31/12/2009
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Lay summary
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http://www.cancerhelp.org.uk/trials/a-trial-to-find-the-best-way-of-controlling-pain-during-and-after-pleurodesis
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Ethics approval
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West Essex Local Research Ethics Committee on 24/04/2006 (ref: 05/Q0301/61)
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Study design
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2 x 2 randomised factorial trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Malignant pleural effusion, including mesothelioma
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Participants - inclusion criteria
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1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis
Definitions:
1.1. Histologically proven pleural malignancy
1.2. Typical features of pleural malignancy seen on direct vision during thoracoscopy
1.3. Pleural effusion in the context of histologically proven cancer elsewhere
2. Written informed consent
3. Expected survival more than one month
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Participants - exclusion criteria
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1. Age less than 18 years
2. Primary lymphoma or small cell lung carcinoma
3. Patients who are pregnant or lactating
4. Inability to give informed consent
5. History of gastrointestinal (GI) bleeding or of untreated peptic ulceration
6. Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) or opiates
7. Hypercapnic ventilatory failure
8. Known intravenous drug abuse
9. Severe renal or liver disease
10. Known bleeding diathesis
11. Warfarin therapy which must be continued
12. Current or recent (within two weeks) corticosteroid steroid therapy
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Anticipated start date
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26/03/2007
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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320 (interim analysis after 120 patients)
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Interventions
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Participants will undergo normal care (thoracoscopy and talc poudrage or talc slurry pleurodesis via drain), using standardised pre-procedure sedation and analgesia as per protocol. The sizes of chest tubes to be used are predefined (large [24F] and small [12F]). The analgesic regimens are:
1. NSAID: ibuprofen 800 mg three times daily (tds) to a maximum of 8-hourly
2. Opiate: diamorphine 2.5 mg, intravenous (IV) administration, four times daily (qds) to a maximum of 10 mg
3. Rescue: patients will always have access to rescue analgesia as required (diamorphine 2.5 mg IV)
Treatment continues from pleurodesis (day 0) to tube removal (day 3).
Participants will be randomised to one of the following arms:
1. Large bore (24F) chest drain and NSAID based analgesic regimen
2. Small bore (12F)chest drain and NSAID based analgesic regimen
3. Large bore chest drain (24F) and opiate based analgesic regimen
4. Small bore chest drain (12F) and opiate based analgesic regimen
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Primary outcome measure(s)
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Pain score over 72 hours post pleurodesis for malignant pleural effusion, taken by administering 100 mm visual analogue pain score (VAS), to calculate the total pain relief (TOTPAR) score, over 3 days
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Secondary outcome measure(s)
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1. Success of pleurodesis at six weeks and three months post randomisation (time to relapse of pleural effusion, survival analysis)
2. Presence of chronic chest pain on the side of the pleurodesis at six weeks and three months post randomisation
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Sources of funding
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University of Oxford (UK)
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Trial website
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Publications
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Contact name
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Dr
Robert
Davies
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Address
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Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LJ
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Country
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United Kingdom
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Sponsor
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University of Oxford (UK)
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Address
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c/o Heather House
Head of Clinical Trials Office
University of Oxford
Manor House
John Radcliffe Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DZ
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Country
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United Kingdom
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Date applied
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11/03/2006
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Last edited
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14/07/2011
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Date ISRCTN assigned
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19/04/2006
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