Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion - Full Text View

Sponsored by:	Oxford Radcliffe Hospital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00644319

Purpose

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.

Condition	Intervention	Phase
Metastatic Cancer	Drug: ibuprofen Drug: morphine sulfate Procedure: management of therapy complications Procedure: pleurodesis	Phase II

Study Type:	Interventional
Study Design:	Supportive Care, Randomized
Official Title:	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]

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 [ Designated as safety issue: No ]
Pleurodesis success at 3 months post randomization (time to relapse of pleural effusion, censored for survival) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization [ Designated as safety issue: No ]
Change in hemoglobin and white cell count from day 0 to day 3 [ Designated as safety issue: Yes ]
Change in renal function and liver function (i.e., ALT or AST, bilirubin, albumin, and alk phos) from day 0 to day 3 [ Designated as safety issue: Yes ]
Change in Inflammatory markers from day 0 and day 3 (e.g., CRP, WCC) from day 0 to day 3 [ Designated as safety issue: Yes ]
Change in alveolar PO2-arterial PO2 (A-a) gradient (on air) on day 0 and day 3 [ Designated as safety issue: Yes ]
Continuous oximetry monitoring from day 0 to day 3 (on air unless saturation < 90%) [ Designated as safety issue: Yes ]
Average conscious level measured by Glasgow Coma scale from day 0 to day 3 [ Designated as safety issue: Yes ]
Drug- and talc-related adverse reactions [ Designated as safety issue: Yes ]
Complications from chest drain insertion [ Designated as safety issue: Yes ]
Presence of chronic chest wall pain assessed at all follow-up visits [ Designated as safety issue: Yes ]

Estimated Enrollment:	320
Study Start Date:	March 2007
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644319

Locations

United Kingdom, England
Oxford Radcliffe Hospital	Recruiting
Oxford, England, United Kingdom, 0X3 9DU
Contact: Contact Person 44-1865-225-205 robert.davies@ndm.ox.ac.uk

Sponsors and Collaborators

Oxford Radcliffe Hospital

Investigators

Principal Investigator:

Robert Davies, MD

Oxford Radcliffe Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000590072, RADCLIFFE-TIME1, ISRCTN33288337, EUDRACT 2006-005226-31, EU-20829, UKCRN 4035
Study First Received:	March 25, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00644319 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

malignant pleural effusion

Study placed in the following topic categories:

Thoracic Neoplasms
Anti-Inflammatory Agents
Morphine
Ibuprofen
Pleural Diseases
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Pleural Effusion, Malignant
Narcotics
Pain

Pleural Effusion
Respiratory Tract Diseases
Analgesics, Non-Narcotic
Neoplasm Metastasis
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Analgesics, Opioid
Pleural Neoplasms

Additional relevant MeSH terms:

Thoracic Neoplasms
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Pleural Effusion, Malignant
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Sensory System Agents
Therapeutic Uses
Neoplasm Metastasis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Analgesics, Opioid

Respiratory Tract Neoplasms
Morphine
Ibuprofen
Pleural Diseases
Cyclooxygenase Inhibitors
Central Nervous System Depressants
Narcotics
Enzyme Inhibitors
Pharmacologic Actions
Pleural Effusion
Neoplasms
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009