The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Naproxen

Placebo

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring Chest tubes, Length of stay, Pleural effusion, Lung resection, Post-operative, Lung cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Naproxen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT01612975

First Posted

June 4, 2012

Last Updated

February 13, 2018

Sponsor

McMaster University

Collaborators

McMaster Surgical Associates

1. Study Identification

Unique Protocol Identification Number

NCT01612975

Brief Title

The Effect of Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

Official Title

The Effect of Perioperative Non-Steroidal Anti-Inflammatory Drug Naproxen on Pleural Effusion Formation After Lung Resection

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

Recruitment futile

Study Start Date

April 2014 (undefined)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

McMaster Surgical Associates

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pleural Effusion, Pleural Effusion Malignant

Keywords

Chest tubes, Length of stay, Pleural effusion, Lung resection, Post-operative, Lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Naproxen

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Naproxen

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Inert, inactive placebo pill similar in appearance to naproxen allocation. To be taken twice daily for 4 weeks total along with 40mg pantoprazole.

Primary Outcome Measure Information:

Title

Change in volume of pleural effusion collected

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Hospital length of stay; compared between intervention and control arms

Description

The length of stay will be measured from the admitting day to the day of discharge to home.

Time Frame

4 weeks

Title

Gastrointestinal complications

Description

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.

Time Frame

4 weeks

Title

General re-admission rates

Description

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.

Time Frame

4 weeks

Title

Total number of days chest tubes remain in-situ

Description

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.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yaron Shargall, MD, BSc, FRCSC

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Healthcare Hamilton

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

15082297

Citation

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.

Results Reference

background

PubMed Identifier

18242249

Citation

Cerfolio 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.

Results Reference

background

PubMed Identifier

17954994

Citation

Suemitsu 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.

Results Reference

background

PubMed Identifier

9387973

Citation

Kroegel 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.

Results Reference

background

PubMed Identifier

20435236

Citation

Scheiman 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.

Results Reference

background

PubMed Identifier

21224324

Citation

Trelle 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.

Results Reference

background

PubMed Identifier

7441518

Citation

Ackerman 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.

Results Reference

background

Links:

URL

http://library.med.utah.edu/WebPath/INFLHTML/INFL062.html

Description

Related Info

Pleural Effusion, Pleural Effusion Malignant

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial