RecruitingNCT03465774

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

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

Enrollment

208 participants

Start Date

Mar 8, 2018

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDoxycycline

Receive via IPC

DEVICEIndwelling Catheter

Receive IPC

PROCEDUREQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

OTHERSurvey Administration

Ancillary studies


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03465774


Related Trials