The first Therapeutic Interventions in Malignant Effusion trial
- Conditions
- Malignant pleural effusion, including mesotheliomaCancerMesothelioma
- Registration Number
- ISRCTN33288337
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26720026 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 320
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method <br> 1. Success of pleurodesis at six weeks and three months post randomisation (time to relapse of pleural effusion, survival analysis)<br> 2. Presence of chronic chest pain on the side of the pleurodesis at six weeks and three months post randomisation<br>