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Effectiveness of Doxycycline for Treating Pleural Effusions Related to Cancer in an Outpatient Population (OPUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01411202
Recruitment Status : Recruiting
First Posted : August 8, 2011
Last Update Posted : October 22, 2018
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE June 13, 2011
First Posted Date  ICMJE August 8, 2011
Last Update Posted Date October 22, 2018
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
Time to pleurodesis [ Time Frame: up to 90 days post PleurX insertion ]
measured in days after Pleurx catheter insertion up to 90 days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2011)
  • Pleurodesis rates at 90 days post Pleurx insertion [ Time Frame: 90 days post Pleurx insertion ]
    defined by the BTS guidelines, where complete pleurodesis is defined as lack of fluid re-accumulation, allowing for removal of the pleural catheter. Failed pleurodesis is defined as re-accumulation of fluid and symptoms requiring repeated pleural procedures
  • Number of participants with adverse events [ Time Frame: 90 days post Pleurx insertion ]
    Most common complications include: pleural infection / cellulitis, pain, catheter obstruction and symptomatic loculated effusion. Other adverse events will also be collected.
  • Effects on pulmonary function [ Time Frame: 90 days post Pleurx insertion ]
    Pulmonary Function testing will be performed prior to and post PleurX catheter insertion and prior to each follow up visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effectiveness of Doxycycline for Treating Pleural Effusions Related to Cancer in an Outpatient Population
Official Title  ICMJE Outpatient Pleurodesis Using Sclerosants(OPUS):Comparing Doxycycline Pleurodesis to Continued Drainage With the Pleurx Catheter System in the Treatment of Malignant Pleural Effusions in the Outpatient Setting
Brief Summary

Patients with cancer may experience problems with their breathing due to a fluid accumulation around their lungs called malignant pleural effusion (MPE). This fluid can be drained but draining may not stop the fluid from accumulating again. MPE can cause shortness of breath during activity and at rest leaving patients feeling as though they cannot catch their breath enough to be comfortable. Other symptoms can include pain, cough and weight loss.

One way to stop the fluid from accumulating is to create scar tissue between the lung and chest wall so there is no more room for fluid accumulation. This procedure is called pleurodesis. Pleurodesis is the standard of care at most centres across Canada. This procedure is done by injecting a drug into the space between the lung and chest wall through a catheter, Doxycycline is one of the drugs currently used for this purpose. Traditionally, patients are admitted for pleurodesis, mostly because the size of the catheter used to inject the medication is very large but also because of the potential complications that can happen with these larger chest tubes.

At our centre, most patients with MPE are managed at home with a smaller sized catheter known as a Pleurx catheter. The Pleurx catheter allows patients to remain at home for treatment and trained staff come into the home to both drain the MPE and monitor the patient. Sometimes, patients experience pleurodesis through use of the Pleurx catheter alone.

Pleurodesis with doxycycline can happen faster than with the Pleurx catheter alone. It has been our experience with a limited number of patients that it is safe to perform pleurodesis using the Pleurx catheter for doxycycline injection in an outpatient setting.

Detailed Description

Malignant pleural effusions (MPE) occur in 25 - 50% of malignancies, represent advanced disease and carry with it significant morbidity. It is estimated that 75% of malignant effusions are symptomatic at the time of presentation, with dyspnea being the most common complaint. Cough, weight loss and chest pain may also be presenting symptoms. The diagnosis of MPE often carries with it a poor prognosis with an average survival of 3-9 months. Thus, management of MPE is generally palliative, aimed at alleviating the associated symptoms, while incurring minimal discomfort and disruption of patients activities of daily living. Limiting the number of days spent hospitalized ia also a consideration. Currently, the most common treatment for MPE involves tube thoracostomy and pleurodesis using a sclerosing agent. Use of Doxycycline as a sclerosing agent has been shown to be both safe and efficacious with only minor complications. Traditionally, pleurodesis with Doxycycline has been performed in the inpatient setting.

The Pleurx catheter (Cardinal Biomedical) is the only small bore catheter commercially available that has been specifically designed for long term indwelling drainage of MPE. In order to reduce the chance of dislodgement and minimize infection rates, it is tunnelled under the skin for approximately 5 cm before entering the pleural space. These indwelling catheters can provide excellent symptom control and have also been associated with spontaneous pleurodesis rates comparable to many chemical pleurodesis rates.

Pleurx has been compared to inpatient doxycycline pleurodesis via chest tube with no difference in survival, safety or efficacy noted. However, hospital stay was significantly shorter in the Pleurx group, 1 day versus 6.5 days.

The aim of this study is to determine the effectiveness of outpatient pleurodesis, using doxycycline administered via Pleurx catheter. This will be a randomized clinical trial comparing the time to pleurodesis in patients with malignant pleural effusion receiving doxycycline + Pleurx catheter versus Pleurx catheter alone.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Effusion
Intervention  ICMJE
  • Drug: Doxycycline
    One time injection 500mg of powdered doxycycline reconstituted with 50cc of normal saline via Pleurx catheter
  • Other: normal saline
    One time injection of normal saline (placebo) into Pleurx catheter
Study Arms  ICMJE
  • Experimental: Doxycycline
    Pleurx insertion with injection of 500mg of doxycycline in 50cc of normal saline.
    Intervention: Drug: Doxycycline
  • Placebo Comparator: Normal Saline
    Pleurx insertion with placebo injection of 50cc of normal saline
    Intervention: Other: normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 4, 2011)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Presence of symptomatic and moderate sized (>1/3 of hemithorax) MPE
  2. Persistent malignant pleural effusion that is free-flowing
  3. Symptomatic improvement after therapeutic thoracentesis
  4. Life expectancy of at least three months (duration of study follow-up)
  5. 90% radiographic apposition of parietal and visceral pleura
  6. Residence within 30 minute radius from The Ottawa Hospital

Exclusion Criteria:

  1. Previous lobectomy or pneumonectomy on affected side
  2. Multiple loculations
  3. Trapped or entrapped lung
  4. Untreated pleural infection
  5. Abnormal coagulation profile (INR>1.5 and / or platelet count <50 x 10*9/L)
  6. Planned intrapleural chemotherapy (however participants may receive concomitant systemic chemotherapy, mediastinal radiation therapy or steroids)
  7. Life expectancy less than 3 months
  8. Multiple co-morbidities limiting out-patient management of pleural effusion
  9. Tetracycline / Doxycycline allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rosalie Labelle, MSc 613-737-8899 ext 75256
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01411202
Other Study ID Numbers  ICMJE 2008362-01H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor  ICMJE Ottawa Hospital Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: K. Amjadi, MD, FRCPC Ottawa Hospital
PRS Account Ottawa Hospital Research Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP