An observational study in Pleural Neoplasm, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by M.D. Anderson Cancer Center · Observational
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.
PRIMARY OBJECTIVES:
I. To obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE).
OUTLINE: Patients choose 1 of 2 groups.
GROUP I: Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
GROUP II: Patients undergo IPC placement.
After completion of study treatment, patients are followed up at 10-14 days and then monthly for up to a year.
Outpatients with MPE undergoing IPC placement
Exclusion Criteria:
Patients undergo IPC placement.
Device: Indwelling Catheter · Procedure: Quality-of-Life Assessment · Other: Questionnaire Administration · Other: Survey Administration
Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
Drug: Doxycycline · Device: Indwelling Catheter · Procedure: Quality-of-Life Assessment · Other: Questionnaire Administration · Other: Survey Administration
Receive via IPC
Also known as: Doxycycline Monohydrate
Receive IPC
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Ancillary studies
Time to pleural catheter removal
This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed, the cause for removal will be documented. For the analysis, causes will include removal due to decreased drainage (i.e., as per plan) as well as removal due to complications (e.g. infection, empyema, refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication). We will also analyze time to catheter removal for any cause and conduct pre-specified secondary analyses to evaluate the effect of fluid drainage amount (i.e., how much was being put out from the indwelling pleural catheter (IPC) the day of IPC placement and on the day of doxycycline instillation) and size of residual effusion as assessed by chest x-ray (CXR) (on day of IPC placement and day of doxycycline instillation) on time to catheter removal.
Time frame: Up to 1 year
Recurrence of effusion requiring drainage after IPC
Time frame: Up to 1 year
Indwelling pleural catheters (IPC) complications
Time frame: Up to 1 year
Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D)
Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement.
Time frame: Baseline up to 1 year
Change in dyspnea using Borg score
Will use paired t-test to compare baseline and 1 month Borg scores and utilities. A generalized linear model will be used to evaluate whether other variables have any impact on the pairwise differences between baseline and 1 month.
Time frame: Baseline up to 1 year
Assessment of symptom burden
Time frame: Baseline up to 1 year
Procedure-associated pain
Time frame: Up to 1 year
Need for hospitalization due to pleurodesis pain
Time frame: Up to 1 year
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Pleural Neoplasms
M.D. Anderson Cancer Center