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

This study is currently recruiting participants.
Verified August 2011 by Ottawa Hospital Research Institute
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01411202
First received: June 13, 2011
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Malignant Pleural Effusion
 Drug: Doxycycline
Other: normal saline
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Time to pleurodesis [ Time Frame: up to 90 days post PleurX insertion ] [ Designated as safety issue: No ]
    measured in days after Pleurx catheter insertion up to 90 days


Secondary Outcome Measures:
  • Pleurodesis rates at 90 days post Pleurx insertion [ Time Frame: 90 days post Pleurx insertion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Pulmonary Function testing will be performed prior to and post PleurX catheter insertion and prior to each follow up visit


Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxycycline
Pleurx insertion with injection of 500mg of doxycycline in 50cc of normal saline.
 Drug: Doxycycline
One time injection 500mg of powdered doxycycline reconstituted with 50cc of normal saline via Pleurx catheter
Other Name: Doxycycline
Placebo Comparator: Normal Saline
Pleurx insertion with placebo injection of 50cc of normal saline
 Other: normal saline
One time injection of normal saline (placebo) into Pleurx catheter

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411202

Contacts
Contact: Chantal Bornais, RN, BScN 613-737-8899 ext 75128 cbornais@toh.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Principal Investigator: K. Amjadi, MD, FRCPC            
Sub-Investigator: N. Voduc, MD            
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: K. Amjadi, MD, FRCPC Ottawa Hospital
  More Information

No publications provided

Responsible Party: Dr. K. Amjadi, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01411202     History of Changes
Other Study ID Numbers: 2008362-01H
Study First Received: June 13, 2011
Last Updated: August 4, 2011
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Malignant Pleural Effusion
Doxycycline
Pleurodesis
Pleurx catheter

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 23, 2013