Recruiting
Phase 2

Doxycycline

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT01411202

Conditions

Malignant Pleural Effusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxycycline

normal saline

Study Details

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.

Conditions

Malignant Pleural Effusion

Study ID

NCT01411202

Start date

Jun, 2011

Status verified date

Sep, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Doxycycline

Pleurx insertion with injection of 500mg of doxycycline in 50cc of normal saline.

placebo comparator: Normal Saline

Pleurx insertion with placebo injection of 50cc of normal saline

Interventions

Doxycycline

One time injection 500mg of powdered doxycycline reconstituted with 50cc of normal saline via Pleurx catheter

normal saline

One time injection of normal saline (placebo) into Pleurx catheter

Primary outcome measure

  • Time to pleurodesis [ Time Frame: up to 90 days post PleurX insertion ]

Central Contacts and Locations

Central contacts

Locations

Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Principal Investigator:

Kayvan Amjadi, MD

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Principal Investigator:

K. Amjadi, MD, FRCPC

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Sep 25, 2020

Last verified

Sep, 2020

Keywords

  • Malignant Pleural Effusion
  • Doxycycline
  • Pleurodesis
  • Pleurx catheter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2020-09-25.