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 a Large Bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion [TIME1]
18 Years
N/A
Both
Metastatic Cancer
Trial Information
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 a Large Bore Chest Tubes in Pleurodesis for Malignant Pleural Effusion [TIME1]
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Robert Davies, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Oxford Radcliffe Hospital
Authority:
Unspecified
Study ID:
CDR0000590072
NCT ID:
NCT00644319
Start Date:
March 2007
Completion Date:
Related Keywords:
- Metastatic Cancer
- malignant pleural effusion
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Pleural Effusion
- Pleural Effusion, Malignant
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