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| [ ...Back to search results ] | [ Print-friendly version ] |
| The first Therapeutic Interventions in Malignant Effusion trial |
| Source of record | UK Trials |
| ISRCTN | ISRCTN33288337 |
| Date ISRCTN assigned | 19/04/2006 |
| Local reference number(s) | 1.1 |
| Public title | The first Therapeutic Interventions in Malignant Effusion trial |
| Scientific title | |
| Acronym | TIME 1 |
| Disease/condition/study domain | Malignant pleural effusion, including mesothelioma |
| Study hypothesis | 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. |
| Design/methodology | 2 x 2 Randomised factorial trial |
| Research ethics review | Ethical approval not yet received as of 19/04/06 |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis Definitions: a. Histologically proven pleural malignancy b. Typical features of pleural malignancy seen on direct vision during thoracoscopy c. Pleural effusion in the context of histologically proven cancer elsewhere 2. Written informed consent 3. Expected survival more than one month |
| Participants - exclusion criteria | 1. Age <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 |
| Patient information material | |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/09/2008 |
| Status of trial | Ongoing |
| Target number of participants | 320 (interim analysis after 120 patients) |
| Interventions | 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 |
| Primary outcome measure(s) | 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 |
| Secondary outcome measure(s) | 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 |
| Sources of funding | University of Oxford |
| Sponsor name | University of Oxford (UK) |
| Sponsor details | c/o Heather House Head of Clinical Trials Office University of Oxford Manor House John Radcliffe Hospital Headington Oxford United Kingdom OX3 9DZ |
| Contact name | Dr Robert Davies |
| Contact details | Oxford Centre for Respiratory Medicine Churchill Hospital Old Road Headington Oxford United Kingdom OX3 7LJ |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN33288337 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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