Metastatic CancerPhase 2NCT00644319
Ibuprofen or Morphine in Treating Pain in Patients Undergoing Pleurodesis for Malignant Pleural Effusion
A Phase 2 study testing ibuprofen, morphine sulfate and management of therapy complications in people with Metastatic Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- ibuprofen, morphine sulfate and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2007to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DU
Contact Person, 44-1865-225-205, robert.davies@ndm.ox.ac.uk
About this study
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]
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.
Read the 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.
- Conditions
- Metastatic Cancer
- Being tested
- ibuprofen, morphine sulfate, management of therapy complications, pleurodesis
- Keywords
- malignant pleural effusion
- Medical subject headings
- Neoplasm Metastasis, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
morphine sulfateDrug
management of therapy complicationsProcedure or surgery
pleurodesisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (10)
Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization
Change in hemoglobin and white cell count from day 0 to day 3
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%)
Average conscious level measured by Glasgow Coma scale from day 0 to day 3
Drug- and talc-related adverse reactions
Complications from chest drain insertion
Presence of chronic chest wall pain assessed at all follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Robert Davies, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644319
- Sponsor's protocol ID
- CDR0000590072
- Other IDs
- RADCLIFFE-TIME1, ISRCTN33288337, EUDRACT 2006-005226-31, EU-20829, UKCRN 4035
- Status last verified
- Jul 2009
- First submitted
- 25 Mar 2008
- Last updated
- 8 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT00644319
- Acronym / sponsor ID
- CDR0000590072
- Conditions
- Metastatic Cancer
- Keywords
- malignant pleural effusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2009 (estimated)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ibuprofen | Drug | – |
| morphine sulfate | Drug | – |
| management of therapy complications | Procedure or surgery | – |
| pleurodesis | Procedure or surgery | – |
Primary outcome
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)
10 secondary outcomes
Presence of chronic chest pain on the side of the pleurodesis at 6 weeks and 3 months post randomization
Change in hemoglobin and white cell count from day 0 to day 3
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%)
Average conscious level measured by Glasgow Coma scale from day 0 to day 3
Drug- and talc-related adverse reactions
Complications from chest drain insertion
Presence of chronic chest wall pain assessed at all follow-up visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Davies, MD principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ibuprofen, morphine sulfate and management of therapy complications in people with Metastatic Cancer, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary 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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2009; AzTrials last refreshed its copy on 8 Nov 2026.