Effectiveness of Doxycycline for Treating Pleural Effusions Related to Cancer in an Outpatient Population
Information source: Ottawa Hospital Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Pleural Effusion
Intervention: Doxycycline (Drug); normal saline (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Ottawa Hospital Research Institute Official(s) and/or principal investigator(s): K. Amjadi, MD, FRCPC, Principal Investigator, Affiliation: Ottawa Hospital
Overall contact: Rosalie Labelle, MSc, Phone: 613-737-8899, Ext: 78198, Email: rolabelle@toh.on.ca
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Time to pleurodesis
Secondary outcome: Pleurodesis rates at 90 days post Pleurx insertionNumber of participants with adverse events Effects on pulmonary function
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rosalie Labelle, MSc, Phone: 613-737-8899, Ext: 78198, Email: rolabelle@toh.on.ca
Ottawa Hospital, Ottawa, Ontario K1H 8L6, Canada; Recruiting Kayvan Amjadi, MD, Principal Investigator
The Ottawa Hospital, Ottawa, Ontario K1H8L6, Canada; Recruiting K. Amjadi, MD, FRCPC, Principal Investigator N. Voduc, MD, Sub-Investigator
Additional Information
Starting date: June 2011
Last updated: January 6, 2015
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