Pleural EffusionPhase 2NCT01612975
The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection
A Phase 2 study testing Naproxen in people with Pleural Effusion and Pleural Effusion Malignant, run by McMaster University at 1 site in Canada.
Trial summary
Following a lung resection procedure, patients have their pleural space drained of fluid that accumulates due to the severing of proximal vessels like lymph nodes. The volume of fluid pumped depends on the severity of the inflammation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pleural Effusion, Pleural Effusion Malignant
- What is being tested?
- Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Jan 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 18 years of age or older
- Participants must be undergoing a major lung resection due to primary or secondary malignancy
- Must have an aptitude for following directions and commitment to the study
Who cannot join
- Patients who are unable to read and communicate in English
- Patients undergoing a pneumonectomy or Open lung resection
- Previous treatments on the same anatomical side including chemotherapy, radiation therapy, and radio-frequency ablation
- Patients who have undergone decortication for empyema or malignancy.
- Patients who have a chest tube in-situ for persistent air leak
- Patients with clinical or laboratory indicators of renal failure, defined as serum creatinine level of 170µmol/l
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- Patients with active or previous history of peptic ulcer disease
- Patients with a known intolerance to Proton Pump Inhibitors (PPIs)
- Known allergy to study drugs
- Use of NSAIDs 4 weeks prior to randomization or on-going use of NSAIDs.
- The use of any medications known to reduce inflammation, including but not limited to: steroids (both oral and intravenously), methotrexate, COX-II inhibitors, other NSAIDs
- Chest tube for persistent air leak.
- Patients who are pregnant or lactating
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection
Following a lung resection procedure, patients have their pleural space drained of fluid that accumulates due to the severing of proximal vessels like lymph nodes. The volume of fluid pumped depends on the severity of the inflammation. The investigators are conduction this study to attempt to use painkillers with intrinsic anti-inflammatory action to try and reduce the degree of inflammation in patients' pleural cavity, thus ensuring patients are discharged faster, with a greater comfort level, and a hopefully lower rate of admission.
Read the detailed description
In this study the investigators will attempt to reduce the degree of inflammation (and thus polymorphonuclear leukocyte counts) in the pleural space following a lung resection procedure by administering the Non Steroid Anti-Inflammatory Drug (NSAID) Naproxen in tandem with Proton Pump Inhibitor (PPI) Pantoprazole, ideally leading towards a significantly reduced volume of transudate and exudate generated.
This will be achieved by running a placebo-controlled double blinded randomized control trial where investigators and participants will be blinded so as to eliminate experimenter bias. After screening for suitable participants using stringent inclusion and exclusion criteria, patients will be administered by allied health professionals 500mg Naproxen twice daily and 40mg Pantoprazole once daily, or an identical placebo for four weeks following resection surgery. Patients will undergo a thorough examination during their scheduled follow-up appointments to monitor general vitals as well as possible gastrointestinal complications. The primary outcome is a significant reduction (Δ100ml) of chest fluid extracted in the intervention arm of the study in comparison to that of the control arm. Secondary outcomes will include a reduction in length of stay measured in days between control and intervention arms as well as a reduction in the total number of days chest tubes are retained in-situ. Conditions such as mortality and morbidity, the onset of complications, and general re-admission rates will also be recorded.
- Conditions
- Pleural Effusion, Pleural Effusion Malignant
- Being tested
- Naproxen, Placebo
- Keywords
- Chest tubes, Length of stay, Pleural effusion, Lung resection, Post-operative, Lung cancer
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Intervention arm involves administering 500mg Naproxen BID to participants and 40mg of Pantoprazole in tandem. Pantoprazole will negate gastrointestinal consequences of Naproxen and reduce the likelihood of a complication occurring. Participants will take Naproxen at the above dosage from the time of surgery to four weeks following surgery. They will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. This experiment is double-blinded so neither investigators nor participants will know which arm of the study they belong to.
PlaceboDrug
Inert, inactive placebo pill similar in appearance to naproxen allocation. To be taken twice daily for 4 weeks total along with 40mg pantoprazole.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This study arm will encompass the administration of a placebo (physically identical to Naproxen) orally to participants. Naproxen is a painkiller with intrinsic anti-inflammatory properties, while the placebo has no pharmacological properties associated with it. Participants will also be taking Pantoprazole to negate the gastrointestinal consequences of Naproxen (or the placebo). Participants will not know which arm of the study they belong to. In addition, they will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. Receives: Drug: Placebo |
| Naproxen | Experimental | Intervention arm involves administering 500mg Naproxen twice a day to participants and 40mg of Pantoprazole once a day in tandem. Pantoprazole will negate gastrointestinal consequences of Naproxen and reduce the likelihood of a complication occurring. Participants will take Naproxen at the above dosage from the time of surgery to four weeks following surgery. They will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. This experiment is double-blinded so neither investigators nor participants will know which arm of the study they belong to. Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in volume of pleural effusion collected
The investigators are looking to measure the volume of pleural effusion collected from in-situ chest tubes in patients following a lung resection, measured in mL
Measured: 4 weeks
Secondary outcomes (4)
Hospital length of stay; compared between intervention and control arms
The length of stay will be measured from the admitting day to the day of discharge to home.
Measured: 4 weeks
Gastrointestinal complications
Recorded as a binary event, adverse events related to the gastrointestinal tract may occur in participants undergoing treatment. The extent of this occurrence will determine whether or not further intervention by the Data and Safety Monitoring Committee is necessary.
Measured: 4 weeks
General re-admission rates
Participants recently discharged following a lung resection have a chance to be re-admitted for a post-operative complication. This will be measured as a binary event and the total associated length of stay associated with the episode.
Measured: 4 weeks
Total number of days chest tubes remain in-situ
This outcome is related to the volume of pleural effusion produced and will measure the time chest tubes remain in place following surgery, measured in days.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startApr 2014
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Recruitment futile
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Surgical Associates
- Responsible party
- Sponsor
- Investigators
- Yaron Shargall, MD, BSc, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612975
- Sponsor's protocol ID
- SJHHNaproxenRCT
- Status last verified
- Sep 2016
- First submitted
- 4 Jun 2012
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. doi: 10.1016/j.ejcts.2004.01.041.
PubMed 15082297Cerfolio RJ, Bryant AS. Results of a prospective algorithm to remove chest tubes after pulmonary resection with high output. J Thorac Cardiovasc Surg. 2008 Feb;135(2):269-73. doi: 10.1016/j.jtcvs.2007.08.066.
PubMed 18242249Suemitsu R, Ondo K, Fukuyama S, Ueda H. Late-period-onset chylothorax after a pulmonary resection for lung cancer: a case report. Ann Thorac Cardiovasc Surg. 2007 Oct;13(5):345-8.
PubMed 17954994Kroegel C, Antony VB. Immunobiology of pleural inflammation: potential implications for pathogenesis, diagnosis and therapy. Eur Respir J. 1997 Oct;10(10):2411-8. doi: 10.1183/09031936.97.10102411.
PubMed 9387973Scheiman JM, Hindley CE. Strategies to optimize treatment with NSAIDs in patients at risk for gastrointestinal and cardiovascular adverse events. Clin Ther. 2010 Apr;32(4):667-77. doi: 10.1016/j.clinthera.2010.04.009.
PubMed 20435236Trelle S, Reichenbach S, Wandel S, Hildebrand P, Tschannen B, Villiger PM, Egger M, Juni P. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011 Jan 11;342:c7086. doi: 10.1136/bmj.c7086.
PubMed 21224324Ackerman N, Tomolonis A, Miram L, Kheifets J, Martinez S, Carter A. Three day pleural inflammation: a new model to detect drug effects on macrophage accumulation. J Pharmacol Exp Ther. 1980 Dec;215(3):588-95.
PubMed 7441518
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection
- ClinicalTrials.gov ID
- NCT01612975
- Acronym / sponsor ID
- SJHHNaproxenRCT
- Conditions
- Pleural Effusion, Pleural Effusion Malignant
- Keywords
- Chest tubes, Length of stay, Pleural effusion, Lung resection, Post-operative, Lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment futile
- Enrolment
- 7 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Surgical Associates
- Study start
- Apr 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Jun 2012 (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.
Following a lung resection procedure, patients have their pleural space drained of fluid that accumulates due to the severing of proximal vessels like lymph nodes. The volume of fluid pumped depends on the severity of the inflammation. The investigators are conduction this study to attempt to use painkillers with intrinsic anti-inflammatory action to try and reduce the degree of inflammation in patients' pleural cavity, thus ensuring patients are discharged faster, with a greater comfort level, and a hopefully lower rate of admission.
Detailed description
In this study the investigators will attempt to reduce the degree of inflammation (and thus polymorphonuclear leukocyte counts) in the pleural space following a lung resection procedure by administering the Non Steroid Anti-Inflammatory Drug (NSAID) Naproxen in tandem with Proton Pump Inhibitor (PPI) Pantoprazole, ideally leading towards a significantly reduced volume of transudate and exudate generated.
This will be achieved by running a placebo-controlled double blinded randomized control trial where investigators and participants will be blinded so as to eliminate experimenter bias. After screening for suitable participants using stringent inclusion and exclusion criteria, patients will be administered by allied health professionals 500mg Naproxen twice daily and 40mg Pantoprazole once daily, or an identical placebo for four weeks following resection surgery. Patients will undergo a thorough examination during their scheduled follow-up appointments to monitor general vitals as well as possible gastrointestinal complications. The primary outcome is a significant reduction (Δ100ml) of chest fluid extracted in the intervention arm of the study in comparison to that of the control arm. Secondary outcomes will include a reduction in length of stay measured in days between control and intervention arms as well as a reduction in the total number of days chest tubes are retained in-situ. Conditions such as mortality and morbidity, the onset of complications, and general re-admission rates will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThis study arm will encompass the administration of a placebo (physically identical to Naproxen) orally to participants. Naproxen is a painkiller with intrinsic anti-inflammatory properties, while the placebo has no pharmacological properties associated with it. Participants will also be taking Pantoprazole to negate the gastrointestinal consequences of Naproxen (or the placebo). Participants will not know which arm of the study they belong to. In addition, they will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. |
| Naproxen | Experimental | Drug: NaproxenIntervention arm involves administering 500mg Naproxen twice a day to participants and 40mg of Pantoprazole once a day in tandem. Pantoprazole will negate gastrointestinal consequences of Naproxen and reduce the likelihood of a complication occurring. Participants will take Naproxen at the above dosage from the time of surgery to four weeks following surgery. They will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. This experiment is double-blinded so neither investigators nor participants will know which arm of the study they belong to. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be 18 years of age or older
- Participants must be undergoing a major lung resection due to primary or secondary malignancy
- Must have an aptitude for following directions and commitment to the study
Key exclusion criteria (15 listed)
- Patients who are unable to read and communicate in English
- Patients undergoing a pneumonectomy or Open lung resection
- Previous treatments on the same anatomical side including chemotherapy, radiation therapy, and radio-frequency ablation
- Patients who have undergone decortication for empyema or malignancy.
- Patients who have a chest tube in-situ for persistent air leak
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 |
|---|---|---|
| NaproxenIntervention arm involves administering 500mg Naproxen BID to participants and 40mg of Pantoprazole in tandem. Pantoprazole will negate gastrointestinal consequences of Naproxen and reduce the likelihood of a complication occurring. Participants will take Naproxen at the above dosage from the time of surgery to four weeks following surgery. They will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. This experiment is double-blinded so neither investigators nor participants will know which arm of the study they belong to. | Drug | Naproxen |
| PlaceboInert, inactive placebo pill similar in appearance to naproxen allocation. To be taken twice daily for 4 weeks total along with 40mg pantoprazole. | Drug | Placebo |
Primary outcome
Change in volume of pleural effusion collected
Time frame: 4 weeks
The investigators are looking to measure the volume of pleural effusion collected from in-situ chest tubes in patients following a lung resection, measured in mL
4 secondary outcomes
Hospital length of stay; compared between intervention and control arms
Time frame: 4 weeks
Gastrointestinal complications
Time frame: 4 weeks
General re-admission rates
Time frame: 4 weeks
Total number of days chest tubes remain in-situ
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Recruitment futile). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Background: PubMed 15082297Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. doi: 10.1016/j.ejcts.2004.01.041.
- Background: PubMed 18242249Cerfolio RJ, Bryant AS. Results of a prospective algorithm to remove chest tubes after pulmonary resection with high output. J Thorac Cardiovasc Surg. 2008 Feb;135(2):269-73. doi: 10.1016/j.jtcvs.2007.08.066.
- Background: PubMed 17954994Suemitsu R, Ondo K, Fukuyama S, Ueda H. Late-period-onset chylothorax after a pulmonary resection for lung cancer: a case report. Ann Thorac Cardiovasc Surg. 2007 Oct;13(5):345-8.
- Background: PubMed 9387973Kroegel C, Antony VB. Immunobiology of pleural inflammation: potential implications for pathogenesis, diagnosis and therapy. Eur Respir J. 1997 Oct;10(10):2411-8. doi: 10.1183/09031936.97.10102411.
- Background: PubMed 20435236Scheiman JM, Hindley CE. Strategies to optimize treatment with NSAIDs in patients at risk for gastrointestinal and cardiovascular adverse events. Clin Ther. 2010 Apr;32(4):667-77. doi: 10.1016/j.clinthera.2010.04.009.
- Background: PubMed 21224324Trelle S, Reichenbach S, Wandel S, Hildebrand P, Tschannen B, Villiger PM, Egger M, Juni P. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011 Jan 11;342:c7086. doi: 10.1136/bmj.c7086.
- Background: PubMed 7441518Ackerman N, Tomolonis A, Miram L, Kheifets J, Martinez S, Carter A. Three day pleural inflammation: a new model to detect drug effects on macrophage accumulation. J Pharmacol Exp Ther. 1980 Dec;215(3):588-95.
- Related InfoLink provided by the sponsor.
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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.
Yaron Shargall, MD, BSc, FRCSC principal investigator
McMaster University
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 Naproxen in people with Pleural Effusion and Pleural Effusion Malignant, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. 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: stopped early, as of the sponsor's last update on 15 Feb 2018. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Recruitment futile). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in volume of pleural effusion collected (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612975, which also lists 7 linked publications.
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 15 Feb 2018.