Clinical trial

A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions

Name
2017-0973
Description
This study is designed to obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE). Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. The goal of this clinical research study is to learn if adding doxycycline to the use of an IPC can lead to shorter treatment times with IPCs.
Trial arms
Trial start
2018-03-08
Estimated PCD
2025-04-30
Trial end
2025-04-30
Status
Recruiting
Treatment
Doxycycline
Receive via IPC
Arms:
Group I (IPC, doxycycline)
Other names:
Doxycycline Monohydrate
Indwelling Catheter
Receive IPC
Arms:
Group 2 (IPC alone), Group I (IPC, doxycycline)
Quality-of-Life Assessment
Ancillary studies
Arms:
Group 2 (IPC alone), Group I (IPC, doxycycline)
Other names:
Quality of Life Assessment
Questionnaire Administration
Ancillary studies
Arms:
Group 2 (IPC alone), Group I (IPC, doxycycline)
Survey Administration
Ancillary studies
Arms:
Group 2 (IPC alone), Group I (IPC, doxycycline)
Size
208
Primary endpoint
Time to pleural catheter removal
Up to 1 year
Eligibility criteria
Inclusion Criteria: * Outpatients with MPE undergoing IPC placement * Sufficient mental capacity to provide informed consent and answer Short-Form Six-Dimension health index (SF-6D) and Borg score questions * Inpatients that are expected to be discharged within 5 days of receiving an indwelling pleural catheter Exclusion Criteria: * Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax) * Inability or unwillingness to give informed consent * Inability to perform phone call and clinical follow-up at MD Anderson Cancer Center (MDACC) * Pregnancy * Previous intrapleural therapy for MPE on the same side * Eastern Cooperative Oncology Group (ECOG) of 4 and life expectancy =\< 2 weeks * Doxycycline allergy * Extensive loculations or hydropneumothorax or other contraindication to pleurodesis * Chylous effusions associated with malignant disease
Protocol
{'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 208, 'type': 'ESTIMATED'}}
Updated at
2024-03-29

1 organization

1 product

1 indication