NCT03465774Recruiting

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

M.D. Anderson Cancer Center

Start Date

3/8/2018

Completion Date

12/1/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Doxycycline

DEVICE

Indwelling Catheter

PROCEDURE

Quality-of-Life Assessment

OTHER

Questionnaire Administration

OTHER

Survey Administration

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Conditions

Pleural Neoplasm

Locations

M D Anderson Cancer Center

Houston, Texas 77030

United States