Clinical trial · Interventional
The First Therapeutic Intervention in Malignant Pleural Effusion Trial
TIME1: A 2 X 2 Factorial Trial to Assess Whether Non-steroidal Anti-inflammatory Analgesics and Small-bore Chest Tubes Are Less Painful Than Opiate Analgesics and Large-bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Fluid caused by cancer cells may accumulate in the lining of the lung. Draining the fluid with a chest tube may relieve pain and shortness of breath. To stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. This procedure is known as pleurodesis. This sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this. The investigators hope to find the best way to prevent pain during pleurodesis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Effusion | — | UNRESOLVED | — |
| Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Large bore chest drain + NSAID based analgesic regimen | Other | — | UNRESOLVED |
| Large bore chest drain + opiate based analgesic regimen | Other | — | UNRESOLVED |
| Small bore chest drain + NSAID based analgesic regimen | Other | — | UNRESOLVED |
| Small bore chest drain + opiate based analgesic regimen | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Other: Large bore chest drain + NSAID based analgesic regimen
- type
- ACTIVE_COMPARATOR
- label
- 2
- interventionNames
- Other: Small bore chest drain + NSAID based analgesic regimen
- type
- ACTIVE_COMPARATOR
- label
- 3
- interventionNames
- Other: Large bore chest drain + opiate based analgesic regimen
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. The diagnosis may be established by one of: * Histologically proven pleural malignancy OR * Typical features of pleural malignancy seen on direct vision during thoracoscopy OR * Pleural effusion in the context of histologically proven cancer elsewhere 2. Expected survival more than 1 month 3. Written informed consent 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 GI bleeding or of untreated peptic ulceration 6. Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)/opiates/acetaminophen 7. Hypercapnic respiratory failure 8. Known intravenous drug abuse 9. Severe renal or liver disease 10. Known bleeding diathesis 11. Warfarin therapy 12. Current or recent (within 2 weeks) corticosteroid steroid therapy
References
Publications (0)
Data not yet available