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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    208
  • sponsor
    M.D. Anderson Cancer Center
Updated on 26 January 2021
doxycycline
antibiotic
indwelling catheter
pleurodesis

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.

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.

Details
Condition Pleural disorder, Pleural Effusion, Pleural Neoplasm, malignant pleural effusion, Malignant Neoplasms of Respiratory and Intrathoracic Organs, Pleural Diseases
Treatment Fentanyl, questionnaire administration, quality-of-life assessment, surveys, doxycycline, survey administration, indwelling catheter
Clinical Study IdentifierNCT03465774
SponsorM.D. Anderson Cancer Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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