What this study is
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.
What's being tested
- Doxycycline
Intervention · DRUG
Receive via IPC
- Indwelling Catheter
Intervention · DEVICE
Receive IPC
- Quality-of-Life Assessment
Intervention · PROCEDURE
- Questionnaire Administration
Intervention · OTHER
- Survey Administration
Intervention · OTHER
All of Quality-of-Life Assessment, Questionnaire Administration, Survey Administration
Ancillary studies
Study details
- Official title
- A Prospective Observational Cohort Study of Indwelling Pleural Catheters Versus Indwelling Pleural Catheters Plus Doxycycline Pleurodesis for Treatment of Malignant Pleural Effusions
- Sponsor
- M.D. Anderson Cancer Center
- Conditions
- Pleural Neoplasm
- Enrolling
- 208 people
- Starts
- 2018-03-08
- Est. completion
- 2028-12-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openM D Anderson Cancer Center
Houston, Texas, United States
- David Ost · Contact713-792-6238
- David Ost · Principal investigator
Recruiting
Study team
Sponsor
M.D. Anderson Cancer Center
Study ID 2017-0973
Principal investigator
David Ost
M.D. Anderson Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.