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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Pleural Neoplasm

Treatments: Other: Survey Administration; Procedure: Quality-of-Life Assessment; Device: Indwelling Catheter; Drug: Doxycycline; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03465774

2017-0973 (Other Identifier)

NCI-2018-00630 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

208 participants in 2 patient groups

Group 2 (IPC alone)

Description:

Patients undergo IPC placement.

Treatment:

Other: Questionnaire Administration

Device: Indwelling Catheter

Other: Survey Administration

Procedure: Quality-of-Life Assessment

Group I (IPC, doxycycline)

Description:

Patients undergo IPC placement and receive doxycycline via IPC 5 days later.

Treatment:

Other: Questionnaire Administration

Drug: Doxycycline

Device: Indwelling Catheter

Other: Survey Administration

Procedure: Quality-of-Life Assessment