Metastatic Cancer
Conditions
Keywords
malignant pleural effusion
Brief summary
RATIONALE: Morphine and ibuprofen help lessen pain caused by pleurodesis. It is not yet known whether one drug is more effective than the other in lessening pleurodesis-related pain or whether the size of the chest drain tube affects pain. PURPOSE: This randomized clinical trial is studying ibuprofen to see how well it works compared with morphine in treating pain in patients undergoing pleurodesis for malignant pleural effusion.
Detailed description
OBJECTIVES: Primary * To evaluate the efficacy of a non-steroidal based regimen comprising ibuprofen in decreasing post-pleurodesis pain as compared to an opiate-based regimen comprising morphine sulfate in patients with malignant pleural effusion. * To evaluate whether chest drain size influences the amount of post-pleurodesis pain. OUTLINE: This is a multicenter study. Patients are stratified according to histological tissue type (mesothelioma vs non-mesothelioma) and thoracoscopic procedure. Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3. * Arm II: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral ibuprofen 3 times daily for 3 days. The chest tube is removed on day 3. * Arm III: Patients undergo pleurodesis after placement of a large bore chest drain (24F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3. * Arm IV: Patients undergo pleurodesis after placement of a small bore chest drain (12F) on day 0 and receive oral morphine sulfate 4 times daily for 3 days. The chest tube is removed on day 3. All patients will receive regular background analgesia comprising paracetamol 4 times daily on days 0-3. Patients not adequately treated with these regimens may also receive rescue analgesia comprising morphine sulfate IV on days 0-3. After completion of study treatment, patients are followed at 1, 3, and 6 months, and periodically thereafter.
Interventions
Sponsors
Oxford University Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of malignant pleural effusion requiring pleurodesis confirmed by 1 of the following: * Histologically proven pleural malignancy * Typical features of pleural malignancy seen on direct vision during thoracoscopy * Pleural effusion in the context of histologically proven cancer elsewhere * No primary lymphoma or small cell lung carcinoma * All patients undergoing thoracoscopy for suspected malignant pleural effusion are eligible PATIENT CHARACTERISTICS: * Life expectancy \> 1 month * Not pregnant or nursing * No history of GI bleeding or untreated peptic ulceration * No known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), opiates, or paracetamol * No hypercapnic respiratory failure * No known intravenous drug abuse * No severe renal or liver disease * No known bleeding diathesis * Able to give informed consent PRIOR CONCURRENT THERAPY: * More than 2 weeks since prior and no concurrent corticosteroid therapy * No concurrent warfarin therapy * No other concurrent analgesics * Analgesics used as a breakthrough regimen are allowed from trial entry to tube withdrawal at day 3 post-pleurodesis (i.e., regular paracetamol, assigned study analgesia, and breakthrough medication only, including opiate slow release patches) * No concurrent enrollment on another clinical study * Patients may participate in other trials immediately after completion of current trial, excluding those involving further pleural procedures or analgesia trials in which patients must wait at least 3 months after completion of current trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average pain score over 72 hours post pleurodesis (total pain relief score) by a Visual Analogue Scale of pain relief and pain intensity every 6 hours | — |
| Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion, censored for survival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in renal function and liver function (i.e., ALT or AST, bilirubin, albumin, and alk phos) from day 0 to day 3 | — |
| Change in Inflammatory markers from day 0 and day 3 (e.g., CRP, WCC) from day 0 to day 3 | — |
| Change in alveolar PO2-arterial PO2 (A-a) gradient (on air) on day 0 and day 3 | — |
| Continuous oximetry monitoring from day 0 to day 3 (on air unless saturation < 90%) | — |
| Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization | — |
| Drug- and talc-related adverse reactions | — |
| Complications from chest drain insertion | — |
| Presence of chronic chest wall pain assessed at all follow-up visits | — |
| Average conscious level measured by Glasgow Coma scale from day 0 to day 3 | — |
| Change in hemoglobin and white cell count from day 0 to day 3 | — |
Countries
United Kingdom
Outcome results
None listed