Indwelling Pleural Catheters With or Without Doxycycline in Treating Patients With Malignant Pleural Effusions

Recruiting

• Conditions: Pleural Neoplasm
• Interventions: Drug: Doxycycline; Device: Indwelling Catheter; Procedure: Quality-of-Life Assessment; Other: Survey Administration; Other: Questionnaire Administration

• Registration Number: NCT03465774
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-03-08
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (IPC alone)	Quality-of-Life Assessment	Patients undergo IPC placement.
Group 2 (IPC alone)	Survey Administration	Patients undergo IPC placement.
Group I (IPC, doxycycline)	Doxycycline	Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
Group I (IPC, doxycycline)	Survey Administration	Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
Group 2 (IPC alone)	Indwelling Catheter	Patients undergo IPC placement.
Group I (IPC, doxycycline)	Quality-of-Life Assessment	Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
Group I (IPC, doxycycline)	Questionnaire Administration	Patients undergo IPC placement and receive doxycycline via IPC 5 days later.
Group 2 (IPC alone)	Questionnaire Administration	Patients undergo IPC placement.
Group I (IPC, doxycycline)	Indwelling Catheter	Patients undergo IPC placement and receive doxycycline via IPC 5 days later.

Primary Outcome Measures

Name	Time	Method
Time to pleural catheter removal	Up to 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Procedure-associated pain	Up to 1 year
Need for hospitalization due to pleurodesis pain	Up to 1 year
Quality-adjusted survival measured using Short-Form Six-Dimension health index (SF-6D)	Baseline up to 1 year	Will use the Kaplan-Meier product-limit method to estimate median quality-adjusted life years (QALYs) following IPC placement.
Change in dyspnea using Borg score	Baseline up to 1 year	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.
Recurrence of effusion requiring drainage after IPC	Up to 1 year
Indwelling pleural catheters (IPC) complications	Up to 1 year
Assessment of symptom burden	Baseline up to 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States