Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00644319
First received: March 25, 2008
Last updated: July 7, 2009
Last verified: July 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
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 University Hospitals NHS Trust
Investigators
Principal Investigator: Robert Davies, MD Oxford University Hospitals NHS Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00644319     History of Changes
Other 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
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
malignant pleural effusion

Additional relevant MeSH terms:
Neoplasm Metastasis
Pleural Effusion
Pleural Effusion, Malignant
Neoplastic Processes
Neoplasms
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Morphine
Ibuprofen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014