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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Treatments: Doxycycline

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