Effectiveness of Doxycycline for Treating Pleural Effusions Related to Cancer in an Outpatient Population
OPUS
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
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2011
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 13, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedSeptember 25, 2020
September 1, 2020
10.6 years
June 13, 2011
September 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to pleurodesis
measured in days after Pleurx catheter insertion up to 90 days
up to 90 days post PleurX insertion
Secondary Outcomes (3)
Pleurodesis rates at 90 days post Pleurx insertion
90 days post Pleurx insertion
Number of participants with adverse events
90 days post Pleurx insertion
Effects on pulmonary function
90 days post Pleurx insertion
Study Arms (2)
Doxycycline
EXPERIMENTALPleurx insertion with injection of 500mg of doxycycline in 50cc of normal saline.
Normal Saline
PLACEBO COMPARATORPleurx insertion with placebo injection of 50cc of normal saline
Interventions
One time injection 500mg of powdered doxycycline reconstituted with 50cc of normal saline via Pleurx catheter
Eligibility Criteria
You may qualify if:
- Presence of symptomatic and moderate sized (\>1/3 of hemithorax) MPE
- Persistent malignant pleural effusion that is free-flowing
- Symptomatic improvement after therapeutic thoracentesis
- Life expectancy of at least three months (duration of study follow-up)
- % radiographic apposition of parietal and visceral pleura
- Residence within 30 minute radius from The Ottawa Hospital
You may not qualify if:
- Previous lobectomy or pneumonectomy on affected side
- Multiple loculations
- Trapped or entrapped lung
- Untreated pleural infection
- Abnormal coagulation profile (INR\>1.5 and / or platelet count \<50 x 10\*9/L)
- Planned intrapleural chemotherapy (however participants may receive concomitant systemic chemotherapy, mediastinal radiation therapy or steroids)
- Life expectancy less than 3 months
- Multiple co-morbidities limiting out-patient management of pleural effusion
- Tetracycline / Doxycycline allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H8L6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
K. Amjadi, MD, FRCPC
Ottawa Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2011
First Posted
August 8, 2011
Study Start
June 1, 2011
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
September 25, 2020
Record last verified: 2020-09